Event Notification Report for June 30, 2021
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
06/29/2021 - 06/30/2021
Agreement State
Event Number: 55221
Rep Org: RI DEPT OF RADIOLOGICAL HEALTH
Licensee: Electric Boat Corporation
Region: 1
City: North Kingstown State: RI
County:
License #: 3D-005-01
Agreement: Y
Docket:
NRC Notified By: Alexander Hamm
HQ OPS Officer: Joanna Bridge
Licensee: Electric Boat Corporation
Region: 1
City: North Kingstown State: RI
County:
License #: 3D-005-01
Agreement: Y
Docket:
NRC Notified By: Alexander Hamm
HQ OPS Officer: Joanna Bridge
Notification Date: 04/29/2021
Notification Time: 13:59 [ET]
Event Date: 03/07/2021
Event Time: 01:20 [EDT]
Last Update Date: 06/29/2021
Notification Time: 13:59 [ET]
Event Date: 03/07/2021
Event Time: 01:20 [EDT]
Last Update Date: 06/29/2021
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
SCHROEDER, DAN (R1DO)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
SCHROEDER, DAN (R1DO)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
EN Revision Imported Date: 6/30/2021
EN Revision Text: AGREEMENT STATE REPORT - RADIOGRAPHY CAMERA SOURCE UNABLE TO RETRACT
The following was received via e-mail from the Rhode Island Dept. of Health, Radiation Control Agency:
"A licensee, Electric Boat Corporation, reported the inability to retract a 1.62 TBq (43.8 Ci) Co-60 source (QSA Global, Inc. Model A424-14, S/N 81346G) into the radiography exposure device (QSA Global, Inc. Model Sentry 330, S/N P30106) on March 7, 2021, at Electric Boat's Quonset Point Facility. At approximately 0120 [EDT], the [source] was [extended] without any issue.
"At the completion of the exposure, the radiographer attempted to retract the source into the exposure device, and attempted to re-expose the source to verify that the auto-locking mechanism on the Sentry 330 exposure device had engaged. At this time, the radiographer noted that the auto-lock did not engage and that dose rates indicated by his ND-2000A survey instrument at the reel (remote control) remained at approximately 10 mrem/hr. The radiographer then attempted to expose and retract the source to engage the locking mechanism 2 additional times without success.
"At approximately 0156 [EDT], the RSO [(Radiation Safety Officer)] was notified of the inability to retract a Cobalt-60 source into its exposure device. The RSO was able to observe the set up with an inspection mirror from the opposite side of the large part being inspected and determined that the guide tube had become disconnected from the collimator, exposing 10-12 feet of drive cable on the deck, and the source pigtail had become stuck in the collimator.
"After creating and briefing retrieval and contingency plans, source retrieval evolution began at 0640 [EDT]. The RSO Delegate secured the source pigtail in the collimator with a 6 ft long remote handling tool to prevent the source from leaving the collimator prematurely while the RSO stepped out from behind the lead shield with another 6 ft long remote handling tool to move the guide tube from the deck back up to the collimator. While the RSO was straightening out the guide tube and drive cable, a radiography supervisor was slowly retracting the drive cable at the reel to remove the 10-12 ft of drive cable slack on the deck while the RSO communicated via radio. Once the drive cable slack was removed and the RSO guided the guide tube back up to the collimator and tension on the source pigtail was released, the RSO Delegate released control of the source and it was immediately retracted by the radiography supervisor into the exposure device. The source was confirmed to be secured in its device by survey, and the evolution was declared secure at 0649 [EDT].
"RI Radiation Control Agency has investigated the report by Electric Boat Corporation and has determined that this does not have generic implications for the security of sources in radiography equipment at Electric Boat Corporation. The incident is considered closed by RI Radiation Control Agency."
* * * UPDATE ON 6/29/21 AT 1617 EDT FROM ALEXANDER HAMM TO BETHANY CECERE * * *
The following update was received via email from the Rhode Island Dept. of Health, Radiation Control Agency:
"Event Causes: 1) The first 1-3 male threads were rough, which lead to the female connection binding up prematurely. 2) The collimator connection was at or above the eye level of the radiographers, and obstructed from being able to perform a visual inspection of the connection. 3) Neither radiographer re-inspected nor verified the connection in the middle of the shift.
"Corrective Actions: By the licensee: 1) 2 collimators with male threads were identified as unsat and will be repaired or dispositioned for disposal by the RSO. 2) Thread protectors were procured and installed on equipment with exposed, male-threaded connections. 3) A Job Instruction Breakdown describing the connection and verification processes was developed."
Notified R1DO (Lilliendahl) and NMSS Events Notification (by email).
EN Revision Text: AGREEMENT STATE REPORT - RADIOGRAPHY CAMERA SOURCE UNABLE TO RETRACT
The following was received via e-mail from the Rhode Island Dept. of Health, Radiation Control Agency:
"A licensee, Electric Boat Corporation, reported the inability to retract a 1.62 TBq (43.8 Ci) Co-60 source (QSA Global, Inc. Model A424-14, S/N 81346G) into the radiography exposure device (QSA Global, Inc. Model Sentry 330, S/N P30106) on March 7, 2021, at Electric Boat's Quonset Point Facility. At approximately 0120 [EDT], the [source] was [extended] without any issue.
"At the completion of the exposure, the radiographer attempted to retract the source into the exposure device, and attempted to re-expose the source to verify that the auto-locking mechanism on the Sentry 330 exposure device had engaged. At this time, the radiographer noted that the auto-lock did not engage and that dose rates indicated by his ND-2000A survey instrument at the reel (remote control) remained at approximately 10 mrem/hr. The radiographer then attempted to expose and retract the source to engage the locking mechanism 2 additional times without success.
"At approximately 0156 [EDT], the RSO [(Radiation Safety Officer)] was notified of the inability to retract a Cobalt-60 source into its exposure device. The RSO was able to observe the set up with an inspection mirror from the opposite side of the large part being inspected and determined that the guide tube had become disconnected from the collimator, exposing 10-12 feet of drive cable on the deck, and the source pigtail had become stuck in the collimator.
"After creating and briefing retrieval and contingency plans, source retrieval evolution began at 0640 [EDT]. The RSO Delegate secured the source pigtail in the collimator with a 6 ft long remote handling tool to prevent the source from leaving the collimator prematurely while the RSO stepped out from behind the lead shield with another 6 ft long remote handling tool to move the guide tube from the deck back up to the collimator. While the RSO was straightening out the guide tube and drive cable, a radiography supervisor was slowly retracting the drive cable at the reel to remove the 10-12 ft of drive cable slack on the deck while the RSO communicated via radio. Once the drive cable slack was removed and the RSO guided the guide tube back up to the collimator and tension on the source pigtail was released, the RSO Delegate released control of the source and it was immediately retracted by the radiography supervisor into the exposure device. The source was confirmed to be secured in its device by survey, and the evolution was declared secure at 0649 [EDT].
"RI Radiation Control Agency has investigated the report by Electric Boat Corporation and has determined that this does not have generic implications for the security of sources in radiography equipment at Electric Boat Corporation. The incident is considered closed by RI Radiation Control Agency."
* * * UPDATE ON 6/29/21 AT 1617 EDT FROM ALEXANDER HAMM TO BETHANY CECERE * * *
The following update was received via email from the Rhode Island Dept. of Health, Radiation Control Agency:
"Event Causes: 1) The first 1-3 male threads were rough, which lead to the female connection binding up prematurely. 2) The collimator connection was at or above the eye level of the radiographers, and obstructed from being able to perform a visual inspection of the connection. 3) Neither radiographer re-inspected nor verified the connection in the middle of the shift.
"Corrective Actions: By the licensee: 1) 2 collimators with male threads were identified as unsat and will be repaired or dispositioned for disposal by the RSO. 2) Thread protectors were procured and installed on equipment with exposed, male-threaded connections. 3) A Job Instruction Breakdown describing the connection and verification processes was developed."
Notified R1DO (Lilliendahl) and NMSS Events Notification (by email).
Part 21
Event Number: 55223
Rep Org: Paragon Energy Solutions
Licensee: Paragon Energy Solutions
Region: 4
City: Fort Worth State: TX
County:
License #:
Agreement: N
Docket:
NRC Notified By: Tracy Bolt
HQ OPS Officer: Joanna Bridge
Licensee: Paragon Energy Solutions
Region: 4
City: Fort Worth State: TX
County:
License #:
Agreement: N
Docket:
NRC Notified By: Tracy Bolt
HQ OPS Officer: Joanna Bridge
Notification Date: 04/29/2021
Notification Time: 19:52 [ET]
Event Date: 03/29/2021
Event Time: 00:00 [CDT]
Last Update Date: 06/29/2021
Notification Time: 19:52 [ET]
Event Date: 03/29/2021
Event Time: 00:00 [CDT]
Last Update Date: 06/29/2021
Emergency Class: Non Emergency
10 CFR Section:
21.21(d)(3)(i) - Defects And Noncompliance
10 CFR Section:
21.21(d)(3)(i) - Defects And Noncompliance
Person (Organization):
SCHROEDER, DAN (R1DO)
MILLER, MARK (R2DO)
RIEMER, KENNETH (R3DO)
PROULX, DAVID (R4DO)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
SCHROEDER, DAN (R1DO)
MILLER, MARK (R2DO)
RIEMER, KENNETH (R3DO)
PROULX, DAVID (R4DO)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
EN Revision Imported Date: 6/30/2021
EN Revision Text: PART 21 - FAILURE OF SIZE 1 AND 2 FREEDOM SERIES FULL VOLTAGE REVERSING STARTERS
The following is a summary of information received from Paragon Energy Solutions:
On 3/29/2021, Dominion - North Anna Station has identified instances where size 1 and 2 starters have failed to function as expected in assemblies that were originally supplied by Nuclear Logistics LLC (NLI). The mechanical interlock exhibited binding that prevented the contactor from closing when energized. The identified failed starters are utilized in an application of operating Motor Operated Valves (MOV). This is an intermittent duty application.
The issue was identified on Eaton Starter Model AN56DN*, AN56GN*, CN55DN*, CN55GN* style starters and contactors with supplied date codes T4514 (week 45 of year 2014) and T4215 (week 42 of year 2015). Paragon is in the process of identifying the date codes to provide the specific information to the identified plants.
The following plants were supplied starters from September 2014 through October 2018: Beaver Valley, Columbia, Ergytech, Harris, Millstone, NEK KRSKO, North Anna, Prairie Island.
The component design that exhibited the failure was revised by the original equipment manufacturer (Eaton) in October 2018. There have been no reported failures of the interlock mechanism in vintages manufactured before September 2014 or after October 2018.
These recommendations are based on the specific application: The reversing starters and reversing contactors are typically wired in a configuration that will electrically lock out one of the contactors when the other one is being energized to prevent both contactors from being energized at the same time. Therefore, the mechanical interlock is not required to prevent both contactors from being closed at the same time when the electrical interlock configuration is being implemented. In this scenario, the mechanical interlocks are not required and can be removed.
The motor control centers that contain the mechanical interlock should be monitored to ensure that there is no binding during operation.
The evaluation being performed by Paragon is expected to be completed by May 29, 2021.
Tracy Bolt
Chief Nuclear Officer, CNO
817-284-0077
Paragon Energy Solutions, LLC
7410 Pebble Drive
Ft. Worth, TX 76118
* * * UPDATE ON 5/3/2021 AT 1559 FROM TRACY BOLT TO BRIAN LIN * * *
The following revision was received from Paragon Energy Solutions via email and corrects the identified date code and includes the size and serial number of the starter that failed:
The issue was identified on supplied Size 1, 73262-025-00028 (Date Code: T4515 - 45th week of 2015) and Size 2, 73262-028-00001 (Date Code: T4215 - 42nd week of 2015).
Notified R1DO (Young), R2DO (Miller), R3DO (Orlikowski), R4DO (Deese), NMSS Events Notification, and Part 21 Group via email.
* * * UPDATE ON 5/28/2021 AT 1558 FROM TRACY BOLT TO KERBY SCALES * * *
The following update (Interim Report) was received from Paragon Energy Solutions via email:
"Paragon is submitting this Interim Report since this condition is currently under evaluation but will not be completed within 60 days.
"Paragon is in communication with EATON, the OEM for the starters/contactors to determine the extent of condition. The evaluation is expected to be completed by June 30, 2021.
"It was determined that Dominion - Millstone should not be included in the list of affected plants. Millstone will be removed from the list in the final revision of P21-03302021."
Notified R1DO (Bower), R2DO (Miller), R3DO (Feliz-Adorno), R4DO (Gepford), NMSS Events Notification, and Part 21 Group via email.
* * * UPDATE ON 6/29/2021 AT 1658 EDT FROM TRACY BOLT TO BETHANY CECERE * * *
The following is a synopsis of an update (completion of the evaluation) received from Paragon Energy Solutions via email:
"Paragon has identified the date codes of the supplied starters and contactors to provide the specific information to the identified plants. This information has been provided directly to the specific plant." [Millstone was removed from the list of plants.]
"The component design that exhibited the failure was revised by the original equipment manufacturer (EATON) in September of 2014. The failed units were from Date Codes T4215 and T4515 which are in the 42nd and 45th weeks of 2015. In September 2018 the drawing was revised again. In discussions with the OEM the revision of the drawing was due to a change in material type and was not a result of binding issues.
"This condition has not been identified on assemblies manufactured after September 2018.
"Due to the number of starters that have been installed and in service without issue, it is highly unlikely that there is a defect within all the supplied starters in the date range of September 2014 through September 2018. To date, Paragon has been unable to obtain any conclusive information from EATON regarding the potential cause of the binding issue. One of the failed starters along with samples of binding and non-binding interlocks have been provided to EATON for them to perform their own analysis on the potential causes of the binding issue.
"Until more information is gathered from the OEM (EATON) Paragon recommends the following:
"The reversing starters and reversing contactors are typically wired in a configuration that will electrically lock out one of the contactors when the other one is being energized to prevent both contactors from being energized at the same time. Therefore, the mechanical interlock is not required to prevent both contactors from being closed at the same time when the electrical interlock configuration is being implemented. In this scenario, the mechanical interlocks are not required and can be removed at the plant's discretion.
"Replacement mechanical interlocks may be ordered to replace the existing interlocks from the affected date code range if the plant application will not allow for removal.
"The motor control center cubicles or starter assemblies with date codes within the September 2014 through September 2018 range should be monitored to ensure that there is no binding during operation. It is possible that if the starter is found to bind during operation, the bound condition could be released by cycling the power to the starter. This action may release the bound condition and will allow the starter to operate."
Notified R1DO (Lilliendahl), R2DO (Miller), R3DO (Stone), R4DO (Werner), NMSS Events Notification, and Part 21 Group via email.
EN Revision Text: PART 21 - FAILURE OF SIZE 1 AND 2 FREEDOM SERIES FULL VOLTAGE REVERSING STARTERS
The following is a summary of information received from Paragon Energy Solutions:
On 3/29/2021, Dominion - North Anna Station has identified instances where size 1 and 2 starters have failed to function as expected in assemblies that were originally supplied by Nuclear Logistics LLC (NLI). The mechanical interlock exhibited binding that prevented the contactor from closing when energized. The identified failed starters are utilized in an application of operating Motor Operated Valves (MOV). This is an intermittent duty application.
The issue was identified on Eaton Starter Model AN56DN*, AN56GN*, CN55DN*, CN55GN* style starters and contactors with supplied date codes T4514 (week 45 of year 2014) and T4215 (week 42 of year 2015). Paragon is in the process of identifying the date codes to provide the specific information to the identified plants.
The following plants were supplied starters from September 2014 through October 2018: Beaver Valley, Columbia, Ergytech, Harris, Millstone, NEK KRSKO, North Anna, Prairie Island.
The component design that exhibited the failure was revised by the original equipment manufacturer (Eaton) in October 2018. There have been no reported failures of the interlock mechanism in vintages manufactured before September 2014 or after October 2018.
These recommendations are based on the specific application: The reversing starters and reversing contactors are typically wired in a configuration that will electrically lock out one of the contactors when the other one is being energized to prevent both contactors from being energized at the same time. Therefore, the mechanical interlock is not required to prevent both contactors from being closed at the same time when the electrical interlock configuration is being implemented. In this scenario, the mechanical interlocks are not required and can be removed.
The motor control centers that contain the mechanical interlock should be monitored to ensure that there is no binding during operation.
The evaluation being performed by Paragon is expected to be completed by May 29, 2021.
Tracy Bolt
Chief Nuclear Officer, CNO
817-284-0077
Paragon Energy Solutions, LLC
7410 Pebble Drive
Ft. Worth, TX 76118
* * * UPDATE ON 5/3/2021 AT 1559 FROM TRACY BOLT TO BRIAN LIN * * *
The following revision was received from Paragon Energy Solutions via email and corrects the identified date code and includes the size and serial number of the starter that failed:
The issue was identified on supplied Size 1, 73262-025-00028 (Date Code: T4515 - 45th week of 2015) and Size 2, 73262-028-00001 (Date Code: T4215 - 42nd week of 2015).
Notified R1DO (Young), R2DO (Miller), R3DO (Orlikowski), R4DO (Deese), NMSS Events Notification, and Part 21 Group via email.
* * * UPDATE ON 5/28/2021 AT 1558 FROM TRACY BOLT TO KERBY SCALES * * *
The following update (Interim Report) was received from Paragon Energy Solutions via email:
"Paragon is submitting this Interim Report since this condition is currently under evaluation but will not be completed within 60 days.
"Paragon is in communication with EATON, the OEM for the starters/contactors to determine the extent of condition. The evaluation is expected to be completed by June 30, 2021.
"It was determined that Dominion - Millstone should not be included in the list of affected plants. Millstone will be removed from the list in the final revision of P21-03302021."
Notified R1DO (Bower), R2DO (Miller), R3DO (Feliz-Adorno), R4DO (Gepford), NMSS Events Notification, and Part 21 Group via email.
* * * UPDATE ON 6/29/2021 AT 1658 EDT FROM TRACY BOLT TO BETHANY CECERE * * *
The following is a synopsis of an update (completion of the evaluation) received from Paragon Energy Solutions via email:
"Paragon has identified the date codes of the supplied starters and contactors to provide the specific information to the identified plants. This information has been provided directly to the specific plant." [Millstone was removed from the list of plants.]
"The component design that exhibited the failure was revised by the original equipment manufacturer (EATON) in September of 2014. The failed units were from Date Codes T4215 and T4515 which are in the 42nd and 45th weeks of 2015. In September 2018 the drawing was revised again. In discussions with the OEM the revision of the drawing was due to a change in material type and was not a result of binding issues.
"This condition has not been identified on assemblies manufactured after September 2018.
"Due to the number of starters that have been installed and in service without issue, it is highly unlikely that there is a defect within all the supplied starters in the date range of September 2014 through September 2018. To date, Paragon has been unable to obtain any conclusive information from EATON regarding the potential cause of the binding issue. One of the failed starters along with samples of binding and non-binding interlocks have been provided to EATON for them to perform their own analysis on the potential causes of the binding issue.
"Until more information is gathered from the OEM (EATON) Paragon recommends the following:
"The reversing starters and reversing contactors are typically wired in a configuration that will electrically lock out one of the contactors when the other one is being energized to prevent both contactors from being energized at the same time. Therefore, the mechanical interlock is not required to prevent both contactors from being closed at the same time when the electrical interlock configuration is being implemented. In this scenario, the mechanical interlocks are not required and can be removed at the plant's discretion.
"Replacement mechanical interlocks may be ordered to replace the existing interlocks from the affected date code range if the plant application will not allow for removal.
"The motor control center cubicles or starter assemblies with date codes within the September 2014 through September 2018 range should be monitored to ensure that there is no binding during operation. It is possible that if the starter is found to bind during operation, the bound condition could be released by cycling the power to the starter. This action may release the bound condition and will allow the starter to operate."
Notified R1DO (Lilliendahl), R2DO (Miller), R3DO (Stone), R4DO (Werner), NMSS Events Notification, and Part 21 Group via email.
Agreement State
Event Number: 55323
Rep Org: NORTH CAROLINA DIV OF RAD PROTECTIO
Licensee: Daimler Trucks
Region: 1
City: Cleveland State: NC
County:
License #: TBD
Agreement: Y
Docket:
NRC Notified By: Travis Cartoski
HQ OPS Officer: Thomas Kendzia
Licensee: Daimler Trucks
Region: 1
City: Cleveland State: NC
County:
License #: TBD
Agreement: Y
Docket:
NRC Notified By: Travis Cartoski
HQ OPS Officer: Thomas Kendzia
Notification Date: 06/23/2021
Notification Time: 11:28 [ET]
Event Date: 06/22/2021
Event Time: 00:00 [EDT]
Last Update Date: 06/23/2021
Notification Time: 11:28 [ET]
Event Date: 06/22/2021
Event Time: 00:00 [EDT]
Last Update Date: 06/23/2021
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
DEBOER, JOSEPH (R1)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
ILTAB, (EMAIL)
DEBOER, JOSEPH (R1)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
ILTAB, (EMAIL)
EN Revision Imported Date: 7/1/2021
EN Revision Text: AGREEMENT STATE REPORT - LOSS OF RADIOACTIVE MATERIAL
The following report was received from the North Carolina (NC) Division of Health Service Regulation via email:
"A NC General Licensee reports the loss of 8 NRD Advanced Static Control devices. Each device contained Po-210 with an activity of 10 mCi, each. General License: TBD as at the time of this report our General License Coordinator is currently unavailable. The licensee reports that the devices may have been inadvertently disposed of and their search continues at this time. This report remains incomplete but shall be updated to complete and close the record."
Advanced Static Control Device:
Manufacturer: NRD Inc.; Model: P-2021-Z705; S/N's: A2MB768, A2MB770, A2MB771, A2MB775, A2MB777, A2MB731, A2MB736, A2MB738
Sources Information:
Po-210 Activity .01 Ci each
NC Item Number: NC210010
THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL
Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf
EN Revision Text: AGREEMENT STATE REPORT - LOSS OF RADIOACTIVE MATERIAL
The following report was received from the North Carolina (NC) Division of Health Service Regulation via email:
"A NC General Licensee reports the loss of 8 NRD Advanced Static Control devices. Each device contained Po-210 with an activity of 10 mCi, each. General License: TBD as at the time of this report our General License Coordinator is currently unavailable. The licensee reports that the devices may have been inadvertently disposed of and their search continues at this time. This report remains incomplete but shall be updated to complete and close the record."
Advanced Static Control Device:
Manufacturer: NRD Inc.; Model: P-2021-Z705; S/N's: A2MB768, A2MB770, A2MB771, A2MB775, A2MB777, A2MB731, A2MB736, A2MB738
Sources Information:
Po-210 Activity .01 Ci each
NC Item Number: NC210010
THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL
Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf
Agreement State
Event Number: 55324
Rep Org: Ohio Department of Health
Licensee: Christ Hospital, Cincinnati
Region: 3
City: Cincinnati State: OH
County:
License #: 02120310008
Agreement: Y
Docket:
NRC Notified By: Micheal Snee
HQ OPS Officer: Thomas Herrity
Licensee: Christ Hospital, Cincinnati
Region: 3
City: Cincinnati State: OH
County:
License #: 02120310008
Agreement: Y
Docket:
NRC Notified By: Micheal Snee
HQ OPS Officer: Thomas Herrity
Notification Date: 06/24/2021
Notification Time: 09:29 [ET]
Event Date: 06/22/2021
Event Time: 00:00 [EDT]
Last Update Date: 06/24/2021
Notification Time: 09:29 [ET]
Event Date: 06/22/2021
Event Time: 00:00 [EDT]
Last Update Date: 06/24/2021
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
STONE, ANN MARIE (R3)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
STONE, ANN MARIE (R3)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
EN Revision Imported Date: 7/1/2021
EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE TO PATIENT
The following was received from the state of Ohio via email:
"Event occurred on 6/22/21. The patient was scheduled for therapy with Y-90 Sir-Spheres. The prescribed dose was 4389 rem. [However, they] administered only 3336 rem, or 76 percent (-24 percent) of the prescribed dose. During the infusion of the Sir-Sphere particles, the infusion catheter became clogged due to the high volume of particles. The catheter was removed, a new catheter placed and used for the infusion of the remaining particles. Stasis was not reached, there was not a patient event, and the estimated difference in dose to the patient exceeds 50 rem to the liver. There were no negative effect to the individual patient, no additional treatment is necessary as a result of this occurrence (administered therapy is sufficient), and no further actions are necessary to prevent recurrence. The physician notified the patient and [their] personal representative of the event, post therapy on 6/22/2021."
Ohio Item Number: OH210005
A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE TO PATIENT
The following was received from the state of Ohio via email:
"Event occurred on 6/22/21. The patient was scheduled for therapy with Y-90 Sir-Spheres. The prescribed dose was 4389 rem. [However, they] administered only 3336 rem, or 76 percent (-24 percent) of the prescribed dose. During the infusion of the Sir-Sphere particles, the infusion catheter became clogged due to the high volume of particles. The catheter was removed, a new catheter placed and used for the infusion of the remaining particles. Stasis was not reached, there was not a patient event, and the estimated difference in dose to the patient exceeds 50 rem to the liver. There were no negative effect to the individual patient, no additional treatment is necessary as a result of this occurrence (administered therapy is sufficient), and no further actions are necessary to prevent recurrence. The physician notified the patient and [their] personal representative of the event, post therapy on 6/22/2021."
Ohio Item Number: OH210005
A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
Non-Agreement State
Event Number: 55326
Rep Org: Curium Pharma
Licensee: Curium Pharma
Region: 3
City: Noblesville State: IN
County:
License #: 13-35179-03
Agreement: N
Docket:
NRC Notified By: Matthew Tressner
HQ OPS Officer: Brian P. Smith
Licensee: Curium Pharma
Region: 3
City: Noblesville State: IN
County:
License #: 13-35179-03
Agreement: N
Docket:
NRC Notified By: Matthew Tressner
HQ OPS Officer: Brian P. Smith
Notification Date: 06/24/2021
Notification Time: 21:56 [ET]
Event Date: 06/24/2021
Event Time: 18:00 [EDT]
Last Update Date: 06/25/2021
Notification Time: 21:56 [ET]
Event Date: 06/24/2021
Event Time: 18:00 [EDT]
Last Update Date: 06/25/2021
Emergency Class: Non Emergency
10 CFR Section:
30.50(a) - Protective Action Prevented 30.50(b)(1) - Unplanned Contamination
10 CFR Section:
30.50(a) - Protective Action Prevented 30.50(b)(1) - Unplanned Contamination
Person (Organization):
NMSS_EVENTS_NOTIFICATION, (EMAIL)
STONE, ANN MARIE (R3DO)
NMSS_EVENTS_NOTIFICATION, (EMAIL)
STONE, ANN MARIE (R3DO)
EN Revision Imported Date: 7/1/2021
EN Revision Text: UNPLANNED CONTAMINATION TO AN INDIVIDUAL
The following synopsis was received via phone call from the licensee's Radiation Safety Officer (RSO):
At 1800 EDT on June 24, 2021 at the licensee facility, an employee left the work site unaware that he was contaminated on his skin and his clothing. The only places the individual traveled to were his car and his home before being called back to work at 1924 EDT to investigate the contamination event. When the individual came back to the facility, contamination was found on his hand including Sr-82, Sr-85, Rb-83, and Rb-84. The activity was 600,000 counts or 0.18 micro curies. Dose calculations have not been performed, however, the RSO does not believe the dose will be near any federal limits. The work area has been decontaminated and the individual's car has been surveyed and no contamination was found. The licensee plans to survey the individual's home as well as contact the NRC Region 3 materials inspector. The licensee is reporting the event under both 30.50(a) and 30.50(b)(1) as a precaution as more data is being collected.
* * * Update from Matthew Trusner to Donald Norwood at 1914 EDT on 6/25/2021 * * *
The following information was received via E-mail:
"On June 24, 2021, at approximately 1800 EDT, Curium-Noblesville RSO became aware of a radioactive spill in a restricted (production) area. The spill occurred behind the production hot cells. The affected area is designated as a triple shoe cover area and cordoned to limit access.
"The RSO directed a Radiation Safety Technician to respond to and initiate the investigation and data collection. The Radiation Safety Technician performed contamination surveys and found a maximum count rate of 800,000 cpm. The Radiation Safety Technician subsequently remediated the spill to 70,000 cpm (below the administrative level of 100,000 cpm) within minutes of completing the survey.
"The spill initiated when a Chemist tried to manually un-crimp a vial containing approximately 695 mCi of Sr-82 and 703 mCi of Sr-85. As the the Chemist tried to un-crimp the vial, the glass below the crimp broke leading to a few drops to fall on the concrete floor behind the hot cells. During the initial investigation surveys, the RSO discovered that the production batch record was contaminated. This prompted the RSO to find the Chemist to ensure he was free of contamination. The RSO discovered that the Chemist had already left the site.
"The RSO immediately contacted the Director of Health Physics for assistance. They made the decision to bring the Chemist onsite for a survey. The RSO discovered that the Chemist's work clothes presented spots reading approximately 600,000 cpm on contact with the pants and 200,000 with the shirt. The RSO also found contamination on the right hand reading approximately 34,000 cpm. Because the Chemist had left the site, the RSO surveyed the Chemist's car and did not identify contamination above background levels. The RSO communicated the findings to the Director of Health Physics and initiated the decontamination activities for the Chemist.
"Prior to decontaminating the Chemist's hand, the RSO obtained a gamma spectrum to identify the radioactive contaminants. He found a mixture of Sr-82, Sr-85, Rb-83 and Rb-84. The Director of Health Physics reviewed the notification requirements prescribed in Part 20 and Part 30 and escalated the event to Curium management and legal teams. Curium made the decision to proactively report the event to the NRC Operations Center under 10 CFR 30.50(a) given that the notification was required within 4 hours of discovery and Curium had not acquired enough data to verify if any regulatory limit was exceeded or not. After the notification, the RSO stopped the decontamination activities after no further contamination was being removed. The RSO measured a residual contamination of 4,200 cpm on the hand. He then followed the Chemist to his home and performed a contamination survey of the areas in which the Chemist indicated that he had been present after leaving the work site that day. The RSO found no contamination above background levels.
"The Director of Health Physics performed an initial dose estimate on June 25, 2021. The RSO used Rb-84 as the most restrictive nuclide that yielded the highest dose in the mixture. The estimates indicated that the Chemist received approximately 1,203 mrem to the maximally exposed shallow dose equivalent (extremity), 636 mrem shallow dose equivalent (whole body) and 13 mrem deep dose equivalent. The RSO performed 24-hour urinalysis and did not find the presence of the radionuclides. All license material was accounted for.
"Curium personnel discussed the incident with NRC Region-III on June 25, 2021. Curium is in the process of completing formal root cause analysis."
Notified R3DO (Stone) and the NMSS Events Notification E-mail group.
EN Revision Text: UNPLANNED CONTAMINATION TO AN INDIVIDUAL
The following synopsis was received via phone call from the licensee's Radiation Safety Officer (RSO):
At 1800 EDT on June 24, 2021 at the licensee facility, an employee left the work site unaware that he was contaminated on his skin and his clothing. The only places the individual traveled to were his car and his home before being called back to work at 1924 EDT to investigate the contamination event. When the individual came back to the facility, contamination was found on his hand including Sr-82, Sr-85, Rb-83, and Rb-84. The activity was 600,000 counts or 0.18 micro curies. Dose calculations have not been performed, however, the RSO does not believe the dose will be near any federal limits. The work area has been decontaminated and the individual's car has been surveyed and no contamination was found. The licensee plans to survey the individual's home as well as contact the NRC Region 3 materials inspector. The licensee is reporting the event under both 30.50(a) and 30.50(b)(1) as a precaution as more data is being collected.
* * * Update from Matthew Trusner to Donald Norwood at 1914 EDT on 6/25/2021 * * *
The following information was received via E-mail:
"On June 24, 2021, at approximately 1800 EDT, Curium-Noblesville RSO became aware of a radioactive spill in a restricted (production) area. The spill occurred behind the production hot cells. The affected area is designated as a triple shoe cover area and cordoned to limit access.
"The RSO directed a Radiation Safety Technician to respond to and initiate the investigation and data collection. The Radiation Safety Technician performed contamination surveys and found a maximum count rate of 800,000 cpm. The Radiation Safety Technician subsequently remediated the spill to 70,000 cpm (below the administrative level of 100,000 cpm) within minutes of completing the survey.
"The spill initiated when a Chemist tried to manually un-crimp a vial containing approximately 695 mCi of Sr-82 and 703 mCi of Sr-85. As the the Chemist tried to un-crimp the vial, the glass below the crimp broke leading to a few drops to fall on the concrete floor behind the hot cells. During the initial investigation surveys, the RSO discovered that the production batch record was contaminated. This prompted the RSO to find the Chemist to ensure he was free of contamination. The RSO discovered that the Chemist had already left the site.
"The RSO immediately contacted the Director of Health Physics for assistance. They made the decision to bring the Chemist onsite for a survey. The RSO discovered that the Chemist's work clothes presented spots reading approximately 600,000 cpm on contact with the pants and 200,000 with the shirt. The RSO also found contamination on the right hand reading approximately 34,000 cpm. Because the Chemist had left the site, the RSO surveyed the Chemist's car and did not identify contamination above background levels. The RSO communicated the findings to the Director of Health Physics and initiated the decontamination activities for the Chemist.
"Prior to decontaminating the Chemist's hand, the RSO obtained a gamma spectrum to identify the radioactive contaminants. He found a mixture of Sr-82, Sr-85, Rb-83 and Rb-84. The Director of Health Physics reviewed the notification requirements prescribed in Part 20 and Part 30 and escalated the event to Curium management and legal teams. Curium made the decision to proactively report the event to the NRC Operations Center under 10 CFR 30.50(a) given that the notification was required within 4 hours of discovery and Curium had not acquired enough data to verify if any regulatory limit was exceeded or not. After the notification, the RSO stopped the decontamination activities after no further contamination was being removed. The RSO measured a residual contamination of 4,200 cpm on the hand. He then followed the Chemist to his home and performed a contamination survey of the areas in which the Chemist indicated that he had been present after leaving the work site that day. The RSO found no contamination above background levels.
"The Director of Health Physics performed an initial dose estimate on June 25, 2021. The RSO used Rb-84 as the most restrictive nuclide that yielded the highest dose in the mixture. The estimates indicated that the Chemist received approximately 1,203 mrem to the maximally exposed shallow dose equivalent (extremity), 636 mrem shallow dose equivalent (whole body) and 13 mrem deep dose equivalent. The RSO performed 24-hour urinalysis and did not find the presence of the radionuclides. All license material was accounted for.
"Curium personnel discussed the incident with NRC Region-III on June 25, 2021. Curium is in the process of completing formal root cause analysis."
Notified R3DO (Stone) and the NMSS Events Notification E-mail group.