Event Notification Report for January 02, 2024

AGREEMENT STATE REPORT - SAFETY EQUIPMENT FAILURE LEAD TO UNDERDOSE

The following information was provided by the Louisiana Department of Environmental Quality (DEQ) via email:

"On December 14, 2023, the licensee was performing a Y-90 procedure. A tubing failure resulted in an incomplete dosing of the patient. All of the unadministered radiopharmaceutical was contained within the administrating device's tubing. There was no spill involved.

"No effect on the individual was determined. Of the prescribed dose of 105 Gy, only 50.5 Gy was administered. The remainder of the prescribed dose is scheduled to be administered on January 2, 2024.

"A representative from TheraSphere was in attendance during the procedure and witnessed the tube failure. The TheraSphere representative alerted their colleagues at Boston Scientific.

"Improvements needed to prevent recurrence: More thorough inspection of device tubing prior to administration."

LA Event Report ID No.: LA20230013

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 - CONTAMINATED PACKAGE

The following information was provided by the California Department of Public Health, Radiation Health Branch (RHB) via email:

"On 12/22/2023, the [University of California, San Francisco] notified RHB that a shipment of F-18 radioactive materials received from SOFIE CO FKA ZEVACOR PHARMA [license number: CA-RML 7131-43] was contaminated. The licensee reported that their contamination wipe tests ranged from 65,000 counts per minute (cpm) to over 100,000 cpm per 300-centimeter squared wipe area using a wipe counter with an efficiency of 25 percent. This amount exceeds the non-fixed radioactive contamination limits specified in Department of Transportation regulations 49 CFR 173.443 of 240 cpm per cm squared for beta and gamma emitters and is reportable under 10 CFR 20.1906(d)(1). RHB is in contact with SOFIE and will be investigating this matter further."

UNANALYZED CONDITION

The following information was provided by the licensee via email:

"Plant alignment caused an unanalyzed condition regarding unit 1 and unit 2 Appendix R procedures.

"[Watts Bar Nuclear] (WBN) unit 1 and unit 2 Appendix R procedures require manual operator action times including [volume control tank] (VCT) isolation. They are calculated with an assumed hydrogen cover gas constant at 20 psig. This is to preclude hydrogen ingestion into the charging pumps with an operator action time of 70 minutes. Due to recent lower hydrogen concentration in the [reactor coolant system] (RCS), [unit 2] VCT hydrogen regulator set point was increased to 28 psig. This increased pressure set point invalidated the initial assumptions made in the Appendix R calculations for manual operator action times.

"WBN unit 1 VCT hydrogen regulator was also verified high out of band at 22 psig.

"WBN has restored unit 1 and unit 2 VCT hydrogen regulators to the required specification.

"The NRC Resident Inspector has been notified of this condition."

EN Revision Imported Date: 1/3/2024

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL UNDERDOSE

The following information was provided by the Kentucky Department for Public Health and Safety, Radiation Health Branch (KY RHB) via email:

"KY RHB was notified on 8/30/2023, at 1700 CDT, by a representative from University of Kentucky Broadscope Medical, of an underdose of a patient during a lutetium 177 (Lu-177) treatment. The underdosing was due to a leakage in the administration line.

"The underdosing was considered more than 20 percent. There was no harm to the patient. A separate report will be submitted once all the facts are gathered."

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.

* * * UPDATE FROM RUSSELL HESTAND TO BRIAN P. SMITH AT 1229 EST ON JANUARY 2, 2024 * * *

The following summary of information was provided by the Kentucky Department of Public Health and Safety, Radiation Health Branch (KY RHB) via email and phone:

Further pertinent information regarding the medical event on Wednesday, August 30, 2023 at Chandler Hospital was identified per KY RHB's 15 day report. The event involved an administration of 200 mCi of Lutathera (Lu-177) via syringe pump where a leak was identified during the infusion. At approximately 20 minutes into the infusion the patient reported a wet feeling on their hand. The infusion was halted immediately. It was identified that a small volume of radioactive liquid was present on the patient's hand having dripped down onto it. The site of the leak was identified to be the connection between the syringe pump apparatus and the patient. Bedding and materials adjacent to the patient were found to have absorbed the majority of the leaked material, though some had also leaked onto the floor coverings. Spill response procedures were immediately initiated as well as notification to the authorized user (AU). Approximately 1/3 of the prescribed activity remained in the syringe. The AU elected to have a new connection established and administer the remainder to the patient.

The licensee estimated the administered activity based on volume of the drug administered, measurements of the contaminated bedding materials, and patient dose rate measurements post infusion (corrected for BMI). These estimates all suggest that this incident resulted in an underdose of approximately 25 percent to 30 percent due to the lost material from the leak. The skin dose to the patient's hand was estimated to conservatively be less than 10 rem (100 mSv). This is well below the level at which any tissue reaction is expected to occur.

Notified R1DO (Bickett), NMSS (Rivera-Capella), NMSS Events Notification (email)

NMED Event Number: 230360