Event Notification Report for June 08, 2021

EN Revision Imported Date: 6/8/2021

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT

The following was received from the state of Iowa via e-mail:

"The licensee reported a potential medical event involving a prostate seed implant therapy. The procedure was performed on April 7, 2021 and the post plan CT scan was conducted on May 27, 2021. The CT scan revealed that a number of seeds were implanted outside of the treatment site. The licensee called and emailed Iowa Department of Public Health (IDPH) Radioactive Materials (RAM) staff on Friday, May 28, 2021. RAM staff, who were out on extended memorial day holiday, did not receive the email or phone message until June 1, 2021 when returning to the office. RAM staff has reached out to the licensee for additional information. RAM staff is intending to conduct a reactive inspection of the licensee [the first week in June]. The licensee will be providing the 15 day written report as required by rule. This event will be updated once the additional information requested from the licensee is received.

"Item Number: IA210002"

* * * UPDATE ON 06/04/2021 AT 1036 EDT FROM RANDAL DAHLIN TO JEFFREY WHITED * * *

The following was received from the Iowa Department of Public Health (IDPH) via e-mail:

"IDPH conducted an onsite investigation on June 3, 2021. This event is being updated based on that investigation.

"It appears that the iodine-125 seeds were implanted correctly on the day of the procedure, but due to swelling of the prostate and the 50 days until the post plan CT when the prostate swelling had reduced, the plan showed 16 seeds outside of the target volume. IDPH staff found no procedural problems with the licensees implant procedure. This possible event will be updated once again when the written report is received from the licensee."

Notified R3DO (Dickson), NMSS EO (Sida) and NMSS Event Notifications (email).

* * * RETRACTION ON 06/07/2021 AT 1527 EDT FROM RANDAL DAHLIN TO LLOYD DESOTELL * * *

The following was received from the Iowa Department of Public Health (IDPH) via e-mail:

"On June 1, 2021 Iowa reported a potential medical event at Spencer Municipal Hospital (License number 0164-1-21-M1) involving Iodine-125 prostate implant seeds. This potential medical event occurred on April 7, 2021 and was discovered by the licensee on May 27, 2021 during their post procedure review. This event was reported to the State on May 28, 2021 and Iowa Department of Public Health (IDPH) Radioactive Materials Program (RAM) staff became aware of the event on June 1, 2021 after the long Memorial Day weekend.

"IDPH RAM staff conducted a reactive inspection at Spencer Municipal Hospital on June 3, 2021 to interview staff involved in the prostate treatment therapy procedure. IDPH staff determined that all seventy-one Iodine-125 seeds were implanted in the correct location of the prostate based on the treatment pre-plan and that when the post procedure CT scan was evaluated it was determined that sixteen seeds had migrated outside of the target volume. Therefore, this does not meet the definition of a reportable medical event per Iowa Administrative Code 641-38.2(136C).

"IDPH program staff had a meeting with NRC Region III staff (Darren Piccirillo and Geoff Warren) via Microsoft Teams on Monday, June 7, 2021 to discuss this potential medical event. Region III staff agreed with IDPH that this seed migration is not a reportable medical event.

"Therefore Iowa is retracting event number 55286 (IA210002)."

Notified R3DO (Kunowski) and NMSS Event Notifications (email).

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.

AUTOMATIC REACTOR TRIP ON TURBINE TRIP DUE TO FAULT AND FIRE IN THE MAIN TRANSFORMER

"At 1527 (Central Standard Time) Unit 2 Reactor tripped caused by a turbine trip due to a fault and fire on Unit 2 Main Transformer #1. All Aux Feedwater Pumps started due to steam generator Lo-Lo levels.

"Unit 2 is being maintained in Hot Standby (Mode 3) in accordance with Integrated Plant Operating Procedure IPO-007B. The Emergency Response Guideline Network has been exited. Decay heat is being rejected to the Main Condenser via the steam dump valves.

"Fire was extinguished at 1546 without offsite assistance. No major injuries reported and no personnel transported offsite for medical attention. Cause of the fault and fire are under investigation.

"NRC Resident Inspector has been notified."

All rods inserted into the core during the trip. There were no relief valves or safety valves lifted during the transient. The plant is stable in its normal shutdown electrical lineup via the auxiliary transformer with all safety equipment available. Unit 1 was not affected by the transient.