Event Notification Report for August 29, 2022
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
08/28/2022 - 08/29/2022
Agreement State
Event Number: 56079
Rep Org: OR Dept of Health Rad Protection
Licensee: Oregon Health and Sciences Univ
Region: 4
City: Portland State: OR
County: Multnomah
License #: ORE-90013
Agreement: Y
Docket:
NRC Notified By: Daryl A. Leon
HQ OPS Officer: Ian Howard
Licensee: Oregon Health and Sciences Univ
Region: 4
City: Portland State: OR
County: Multnomah
License #: ORE-90013
Agreement: Y
Docket:
NRC Notified By: Daryl A. Leon
HQ OPS Officer: Ian Howard
Notification Date: 08/30/2022
Notification Time: 14:10 [ET]
Event Date: 08/29/2022
Event Time: 09:50 [PDT]
Last Update Date: 08/30/2022
Notification Time: 14:10 [ET]
Event Date: 08/29/2022
Event Time: 09:50 [PDT]
Last Update Date: 08/30/2022
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Josey, Jeffrey (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Josey, Jeffrey (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - DOSE LESS THAN PRESCRIBED
The following information was provided by the Oregon Health Authority, Radiation Protection Services via email:
"During preparation for a hepatic microsphere (ThereSphere) treatment, the oncology nurse primed the system but when the needle assembly was snapped into the dose vial a series of bubbles appeared. The nurse attempted to remove the bubbles from the tubing that was to be connected to the patient's catheter but was unsuccessful. The procedure physician was made aware of the bubbles and since the physician did not want to push them through the patient's catheter, the bubbled liquid was expelled into gauze which was subsequently added to the waste container. Working through this issue added approximately 10 minutes to the time between assay and administration.
"In addition, the assayed activity of Y-90 was 96.5 percent of the prescribed dose of 440 Gy and 95.6 percent at time of administration after the 10-minute delay due to the bubbled liquid issue. Normally, 95-99 percent of the assayed activity is delivered to the target (liver), however, with the loss of activity through expelling bubbled liquid, the delivered activity dropped to 351.8 Gy which is greater than the 20 percent lower limit of 440 Gy (352 Gy) at 20.4 percent and makes this a reportable medical event.
"[The physician notified the patient, documented this on the patient's chart, and stated there are no adverse effects from this under-dosing.] No additional dose is needed.
"Cause and corrective actions:
"It was stated the oncology nurse prepped the system 'correctly'. The licensee informed the TheraSphere representative regarding this issue with the needle assembly. At this time, we are unable to determine whether this event is considered human error or defective product.
"It is worthy to note that if one of the two issues (delay of 10 minutes or starting with 96.5 percent) was absent, the under-dosing of greater than 20 percent probably would not have occurred."
Oregon Event Report Number: 22-0038
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.
The following information was provided by the Oregon Health Authority, Radiation Protection Services via email:
"During preparation for a hepatic microsphere (ThereSphere) treatment, the oncology nurse primed the system but when the needle assembly was snapped into the dose vial a series of bubbles appeared. The nurse attempted to remove the bubbles from the tubing that was to be connected to the patient's catheter but was unsuccessful. The procedure physician was made aware of the bubbles and since the physician did not want to push them through the patient's catheter, the bubbled liquid was expelled into gauze which was subsequently added to the waste container. Working through this issue added approximately 10 minutes to the time between assay and administration.
"In addition, the assayed activity of Y-90 was 96.5 percent of the prescribed dose of 440 Gy and 95.6 percent at time of administration after the 10-minute delay due to the bubbled liquid issue. Normally, 95-99 percent of the assayed activity is delivered to the target (liver), however, with the loss of activity through expelling bubbled liquid, the delivered activity dropped to 351.8 Gy which is greater than the 20 percent lower limit of 440 Gy (352 Gy) at 20.4 percent and makes this a reportable medical event.
"[The physician notified the patient, documented this on the patient's chart, and stated there are no adverse effects from this under-dosing.] No additional dose is needed.
"Cause and corrective actions:
"It was stated the oncology nurse prepped the system 'correctly'. The licensee informed the TheraSphere representative regarding this issue with the needle assembly. At this time, we are unable to determine whether this event is considered human error or defective product.
"It is worthy to note that if one of the two issues (delay of 10 minutes or starting with 96.5 percent) was absent, the under-dosing of greater than 20 percent probably would not have occurred."
Oregon Event Report Number: 22-0038
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.
Agreement State
Event Number: 56081
Rep Org: Kentucky Dept of Radiation Control
Licensee: Arkema
Region: 1
City: Calvert City State: KY
County:
License #: 201-308-57
Agreement: Y
Docket:
NRC Notified By: Anjan Bhattacharyya
HQ OPS Officer: Ian Howard
Licensee: Arkema
Region: 1
City: Calvert City State: KY
County:
License #: 201-308-57
Agreement: Y
Docket:
NRC Notified By: Anjan Bhattacharyya
HQ OPS Officer: Ian Howard
Notification Date: 08/31/2022
Notification Time: 15:38 [ET]
Event Date: 08/29/2022
Event Time: 00:00 [CDT]
Last Update Date: 09/02/2022
Notification Time: 15:38 [ET]
Event Date: 08/29/2022
Event Time: 00:00 [CDT]
Last Update Date: 09/02/2022
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Gray, Mel (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Gray, Mel (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
EN Revision Imported Date: 9/7/2022
EN Revision Text: AGREEMENT STATE REPORT - STUCK SHUTTER
The following information was provided by the Kentucky Department for Public Health & Safety, Radiation Health Branch (KY RHB) via email:
"KY RHB was notified by the Radiation Safety Officer (RSO) at Arkema via voicemail and email on 8/30/2022 at 1501 EDT, that on August 30, 2022, one fixed gauging device (Ronan Engineering SA1-F37, Serial Number M8107), containing 5 Ci of Cs-137 (source Serial Number not reported, assay date 08/1991) had developed a problem in that that the shutter arm was not moving freely to the closed position. The technician eventually moved the shutter arm to the closed position and verified radiation levels to be normal. The gauge is mounted on a tank, manned entry is currently restricted, and plant personnel have been notified that there is no access allowed to the vessel. No overexposures were reported due to the malfunction. All operational and maintenance activities related to the vessel will be delayed until the manufacturer (Ronan Engineering) repairs the shutter mechanism. The licensee has contacted the manufacturer/service provider to remediate this situation."
Kentucky Event ID Number: KY220004
*** UPDATE ON 9/2/22 AT 1031 EDT FROM KENTUCKY RADIATION HEALTH BRANCH TO BILL GOTT ***
The following information was provided by the Kentucky Department for Public Health & Safety, Radiation Health Branch (KY RHB) via email:
The KY RHB was informed by the new RSO that the actual date that the shutter malfunction was discovered was April 29, 2022."
Notified R1DO (Gray). Notified via email: NMSS Event Notification
EN Revision Text: AGREEMENT STATE REPORT - STUCK SHUTTER
The following information was provided by the Kentucky Department for Public Health & Safety, Radiation Health Branch (KY RHB) via email:
"KY RHB was notified by the Radiation Safety Officer (RSO) at Arkema via voicemail and email on 8/30/2022 at 1501 EDT, that on August 30, 2022, one fixed gauging device (Ronan Engineering SA1-F37, Serial Number M8107), containing 5 Ci of Cs-137 (source Serial Number not reported, assay date 08/1991) had developed a problem in that that the shutter arm was not moving freely to the closed position. The technician eventually moved the shutter arm to the closed position and verified radiation levels to be normal. The gauge is mounted on a tank, manned entry is currently restricted, and plant personnel have been notified that there is no access allowed to the vessel. No overexposures were reported due to the malfunction. All operational and maintenance activities related to the vessel will be delayed until the manufacturer (Ronan Engineering) repairs the shutter mechanism. The licensee has contacted the manufacturer/service provider to remediate this situation."
Kentucky Event ID Number: KY220004
*** UPDATE ON 9/2/22 AT 1031 EDT FROM KENTUCKY RADIATION HEALTH BRANCH TO BILL GOTT ***
The following information was provided by the Kentucky Department for Public Health & Safety, Radiation Health Branch (KY RHB) via email:
The KY RHB was informed by the new RSO that the actual date that the shutter malfunction was discovered was April 29, 2022."
Notified R1DO (Gray). Notified via email: NMSS Event Notification