Event Notification Report for May 03, 2021

EN Revision Imported Date: 5/3/2021

EN Revision Text: AGREEMENT STATE - PATIENT UNDERDOSE

The following report was received via e-mail from the California Department of Public Health - Radiation Health Branch [CDPH-RHB]:

"On March 13, 2020, the licensee radiation safety officer (RSO) contacted CDPH-RHB to report a medical event which occurred on March 11, 2020, and was discovered on March 13, 2020. The licensee reported that a patient was prescribed 200 mCi of I-131 NaI for the treatment of thyroid cancer, but received only 60 mCi on the day of therapy (March 11, 2020). The 200 mCi dose was divided into two capsules and the patient was unintentionally only provided one of the two capsules in a medicine cup by the authorized user. The second capsule was reportedly stuck in the shipping vial which the authorized user thought he had emptied. The 140 mCi I-131 capsule was returned to the radiopharmacy in the shipping vial and pig. This error was discovered when the radiopharmacy contacted the licensee on March 13, 2020 to inform them of the capsule's presence in the returned vial. The Medical Director of Nuclear Medicine was immediately notified, who in turn, notified the RSO. The referring physician was also notified on March 13, 2020 and took responsibility for notifying the patient. A subsequent dosage was administered to complete the therapeutic treatment.

"This medical event was initially reported to CDPH-RHB by telephone on March 13, 2020 and by written report dated March 27, 2020. However, CDPH-RHB does not believe that the medical event was reported to the NRC at that time. A recent inspection by CDPH-RHB brought this medical event to their current attention."

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.

This material event contains a "Less than Cat 3" level of radioactive material.

EN Revision Imported Date: 5/3/2021

EN Revision Text: AGREEMENT STATE REPORT - STOLEN RADIOLOGICAL DEVICE

The following was received via email from the State of Georgia.

"[The licensee] called and reported a gauge stolen off the back of one of their work trucks on April 22, 2021. The technician responsible for the gauge was working on the Augusta Airport project. The gauge was left locked and chained in the back of his truck in the motel parking lot overnight. The technician last saw the gauge at 1900 EDT on April 21, 2021. When [the technician] went to the truck [on April 22, 2021] the chain and lock had been cut and the gauge removed. The local Sheriff has been informed and the case number is 21-112409. This has been assigned and more information is forthcoming.

Troxler Model Number: 3400
Serial Number: 22667
Activity: Cs-137 (10mCi); Am-241/Be (40 mCi)

Georgia Radioactive Materials Program NMED Report Incident # 40


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 Imported Date: 5/3/2021

EN Revision Text: AGREEMENT STATE REPORT - LOST RADIOLOGICAL DEVICE
The following was received by email from the state of Florida:

"On March 26, 2021, a Co-57 reference vial was left by NMT (Advent Health) with ammo cases in the hotlab for pickup by Jubiliant pharmacy. On March 29, 2021, NMT noted the vial was gone, and later inquired of Jubiliant for transfer paperwork. Jubiliant denied picking up the source. Advent Health has conducted a thorough investigation and search for source and has contacted Jubiliant several more times and have not found the source. Source calibration certificate 07-21-2017, 5.51 mCi [Mfg - Benchmark, Model BM06E, serial # BM06057E17200109]. Jubiliant manager [was contacted]. Advent Health will send in a written report."

Florida Incident Number: FL21-048

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 Imported Date: 5/3/2021

EN Revision Text: UNDER DOSE DELIVERED DURING MEDICAL TREATMENT

The Radiation Safety Officer for the Saint Louis University Hospital called in and emailed the following notification:

"At approximately 1220 CDT on April 23, 2021, Y-90 SIR-Sphere was being administered to a patient. The prescribed dose [for the liver] was 43.2 mCi, the measured dose to be administered was 46.7 mCi, but due to a clog in the catheter, only a calculated 4.53 mCi dose was administered to the patient. Because this exceeds +/- 20 percent of the intended dose, we determined a medical event had occurred. There was no harm to the patient, and a follow-up dose is planned for Monday, April 26, 2021.

"Preliminary Determination of Cause: The cause of the medical event was believed to be clogging of the catheter, but the exact reason for the resistance was undetermined. When the resistance was encountered, the procedure was stopped by the administering physician, with the intention of terminating the procedure, resulting in an administered dose variance greater than +/- 20 percent of the prescribed dose, and thus determined to be a medical event.

"Additional Details:
 The Nuclear Medicine Technologist drew the dose per standard operating procedure. The procedure checklist was read and the dose administration set up was normal. All steps to prevent clumping of microspheres were followed.
 During the administration, the dose was agitated and attempted to be delivered. There was resistance on the plunger during the administration. The physician stated that the catheter was clogged. The procedure was stopped, with the intention to terminate the procedure, and to administer a second dose at a later time.
 The physician disconnected the A-line from the patient catheter. This caused the backpressure to expel the beads onto the administration table and the floor covering. The disposable covering of these surfaces were collected and disposed of in radioactive waste. The Interventional Radiology Suite was surveyed and released, with all wipe tests and G-M survey meter readings at background."

Licensee notified R3 NRC Inspector (O'DOWD)

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 Imported Date: 5/3/2021

EN Revision Text: AGREEMENT STATE REPORT - PATIENT UNDERDOSE

The following is a summary of an email received the State of Washington:

The licensee reported a medical event involving an underdose administration of Y-90 Theraspheres on April 16, 2021. The event resulted in an underdose to the liver. Two vials of Y-90 were to be delivered to two different locations in the liver, however surveys after injection of both vials revealed not all activity in vials made it into the patient. The planned activity for each dose was 0.79 GBq. Post treatment measurement of percent dose delivered for dose `A' and dose `B' was 60 percent and 76 percent, respectively. Gamma camera imagining confirmed no Y-90 Theraspheres in the dose-vial. However, imaging visualized activity retained in the delivery tubing. Routine post-imaging demonstrated microsphere distribution in liver segments 4A and 4B. The activity delivered was 0.465 GBq and 0.594 GBq, respectively.

Washington State Incident Number WA-21-008.

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 Imported Date: 5/3/2021

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

HIGH PRESSURE COOLANT INJECTION (HPCI) DECLARED INOPERABLE

"On 4/29/21 at 2354 [EDT], an alarm was received for U2 HPCI Inverter Power Failure. [It was] identified that the High Pressure Coolant Injection (HPCI) flow controller had lost power due to a failure of an inverter. Without the flow controller, HPCI would not auto start to mitigate the consequences of an accident; thus, HPCI was declared inoperable. All other emergency core cooling systems and reactor core isolation cooling (RCIC) system remain operable.

"HPCI is a single train system with no redundant equipment in the same system; therefore, this failure is reportable as an event or condition that could have prevented fulfillment of a safety function needed to mitigate the consequences of an accident per 10CFR50.72(b)(3)(v)(d).

"The NRC Resident has been informed of this notification."

AUTOMATIC REACTOR TRIP AND ACTUATION OF THE AUXILIARY FEEDWATER SYSTEM

"At 0755 EDT, on May 1, 2021, with Unit 2 in Mode 3 at 0 percent (not critical) power, the reactor trip breakers opened during heat-up activities. The trip was not complex, with all systems responding normally post-trip. At 1013 EDT, on May 1, 2021, with Unit 2 in Mode 3 at 0 percent power, an actuation of the Auxiliary Feedwater (AFW) System occurred. The loss of both main feedwater pump turbines caused an AFW auto-start. The 2A and 2B motor driven auxiliary feedwater (MDAFW) pumps automatically started as designed when the loss of both main feedwater pumps signal was received. The cause of the actuation is still being evaluated.

"Operations responded and stabilized the plant. Decay heat is being removed by the steam generators and discharging steam to the condenser. Unit 1 is not affected.

"Due to the Reactor Protection System (RPS) actuation while not critical and the actuation of the AFW system, this event is being reported as an eight-hour, non-emergency notification per 10 CFR 50.72(b)(3)(iv)(A).

"There was no impact on the health and safety of the public or plant personnel. The NRC Resident Inspector has been notified."