Event Notification Report for June 06, 2025

LOST SOURCE

The following is a summary of information obtained from Sono-Nuclear of Puerto Rico via phone and email:

The licensee received two doses of Pluvicto (Lu-177), each in its own shielded vial, in a single shipping container. One dose was administered without issue, with all contents related to the used dose properly discarded.

The second dose, with an initial activity of 200 mCi, was left to decay for approximately 24 hours for a target final activity of 160 mCi. The dose was left in the original shipping container which had been stripped of all radioactive material transport index labels as usually done when discarding empty boxes after extracting the lead case containing the vial.

On May 29, 2025, at 0701 EDT, a nuclear medicine staff technologist noticed that the shipping container containing the second dose was not in the locked hot lab. The technologist realized that the container was discarded as regular garbage by mistake.

From the licensee's preliminary investigation, it was determined that after work the janitorial staff placed what was thought to be an empty box inside a regular trash bag and discarded it in the waste compactor. The discarded dose vial was enclosed in its protective lead container inside the shipping container. The dose vial was not directly handled, opened, or manipulated by nuclear medicine staff or any other office staff including the janitorial crew. The container was compacted with other waste.

The licensee tried to gain access to the inside of the waste compactor where the box containing the dose was discarded. The licensee was unsuccessful due to not having an access door or space to retrieve items. The licensee is seeking assistance from the company that services the waste compactor.

This waste compactor is located in the far back of the Hospital San Francisco parking lot away from any buildings or parking lots. To assess the radiation exposure of the area, the licensee surveyed the exterior of the waste compactor with maximum readings obtained between 6-7 microrem/hour.

The licensee notified their facility radiation safety officer, medical director, and Hospital San Francisco security staff about the incident.

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 REPORT - MEDICAL EVENT

The following is a summary of information provided by the North Carolina Department of Health and Human Services Radioactive Materials Branch (RMB) via email:

The licensee reported to RMB that around 1500 EDT on 05/29/25, a routine Pluvicto infusion (the second of six planned) presented challenges with gravity delivery of the dose. Staff experienced difficulty initiating forward flow from the saline line into the vial. Attempts to correct the condition were unsuccessful and the procedure was discontinued.

The patient was prescribed to receive 200 mCi of Lu-177 to the prostate but it was calculated the patient only received 117.1 mCi. Post-treatment surveys of the patient were completed; the highest survey reading at one meter was 1.01 mr/hr. Contamination surveys were completed directly after infusion and minimal contamination was found around vial. The tubing, peripheral intravenous (PIV) extensions, and vial were all secured and assayed by radiation safety specialist. Staff moved all waste to disposal and all subsequent area survey readings were at background. The infusion room was cleared for general use. The unused dose was stored for disposal. Staff dosimetry has been sent for processing, but no elevated readings are expected.

The patient was immediately notified of the event and was released. The licensee does not expect the patient's treatment plan to alter due to this event. The medical director also reached out to the patient and referring physician later that day to discuss the event.

After discussions with the radiation safety officer and review of available staff reports, [RMB determined that] the licensee did follow the manufacturer's procedure.

RMB's investigation is ongoing.

NC Event Number: NC250007

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.

UNIT 1 HIGH-PRESSURE COOLANT INJECTION INOPERABLE

The following information was provided by the licensee via phone and email:

"At 2137 EDT on 06/03/2025, while Unit 1 was at 98 percent power in mode 1, the high-pressure coolant injection (HPCI) turbine stop valve failed to open as required when testing the auxiliary oil pump, resulting in the HPCI system being declared inoperable. The cause of the turbine stop valve failing to open is under investigation. HPCI does not have a redundant system, therefore, this condition is being reported as an eight-hour, non-emergency notification per 10 CFR 50.72(b)(3)(v)(D). Reactor core isolation cooling and low-pressure emergency core cooling systems were operable during this time.

"There was no impact on the health and safety of the public or plant personnel. The NRC Resident Inspector has been notified. There was no impact to Unit 2."

INVALID SPECIFIED SYSTEM ACTUATION

The following information was provided by the licensee via phone and email:

"At 2315 EDT on April 11, 2025, the spare train of Unit 2 auxiliary feedwater (AFW), the turbine-driven AFW pump (TDAFWP), automatically started. At the time, Unit 2 was entering a refueling outage and had been shutdown to hot standby conditions. Sufficient makeup water to the steam generators was being supplied by the 'A' and 'B' trains of AFW, [both] motor-driven AFW pumps. Several hours before this automatic start, feed from all main feedwater pumps (MFWPs) and the TDAFWP had been secured.

"The TDAFWP automatically started during the alignment of Unit 2 balance-of-plant to support the outage. As part of the alignment, condenser vacuum for the '2A' MFWP was broken prior to the de-energization of the '2A' MFWP's turbine trip bus. Even though the '2A' MFWP was incapable of providing any main feedwater flow, the order in which these two events were performed appeared to the protective circuitry as a low-vacuum trip of the '2A' MWFP, and thus a loss of all MFWPs. The loss of all MFWPs is an automatic start signal to the TDAFWP.

"This report is being made under 10 CFR 50.73(a)(2)(iv)(A) as an event that resulted in an invalid actuation of the Unit 2 TDAFWP.

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