Event Notification Report for November 08, 2023

EN Revision Imported Date: 11/8/2023

EN Revision Text: MEDICAL EVENT - PATIENT UNDERDOSE

The following information was provided by West Virginia University Hospital via telephone and email:

"It was determined on 8/21/2023, that during a Y-90 (yttrium-90) Thera Sphere treatment performed on 8/17/2023, the delivered dose differed from the prescribed dose by more than 20 percent. The prescribed activity was 101.5 mCi and the administered activity was 3.4 mCi.

"At the start of the infusion the authorized user (AU) was unable to deliver the microspheres due to a blood clot in the microcatheter. The AU then decided to abort the infusion and reschedule instead of chancing potential contamination that could occur by changing out the microcatheter.

"The AU had completed the pre-treatment safety checklist with no issues. The AU has made the notification to the referring physician."


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.

* * * RETRACTION ON NOVEMBER 7, 2023, AT 1207 EST FROM WEST VIRGINIA UNIVERSITY HOSPITAL TO KAREN COTTON * * *

It was determined that the dose of yttrium-90 Thera Spheres was not delivered according to the written directive due to an emergent patient condition. Therefore, the incident does not qualify as a reportable medical event.

The patient's blood formed a clot within the microcatheter which prevented the passage of Y-90 microspheres. At the onset of administration, the Authorized User (AU) encountered significant resistance in the microcatheter, and they could not flush forward. When troubleshooting the delivery set, the AU visually identified the blood clot within the microcatheter. After several unsuccessful attempts to clear the blood clot, and in consultation with representatives from Boston Scientific, the AU decided to terminate the procedure. On September 1st, the Y-90 prescribed activity, as stated on the written directive, was successfully administered to the patient's hepatic artery. There were no adverse effects to the patient because of the underdose incident. The details of this incident were discussed with NRC inspectors who were on site for a reactive inspection. During those discussions it was concluded that since the patient's blood clotted within the microcatheter, the inability to complete the administration was due to an emergent patient condition.

The blood clot within the microcatheter was confirmed by an analysis of the delivery set performed by Boston Scientific's Product Analysis Team.

Notified: R1DO (Elise), NMSS Events Notification (E-mail)

AGREEMENT STATE REPORT - BROKEN CABLE ON EXPOSURE DEVICE

The following information was provided by the Texas Department of State Health Services via email:

"On October 30, 2023, the licensee reported that on October 27, 2023, they had an industrial radiography source disconnect when the drive cable broke at the connector while the crew was working at a temporary job site. The exposure device was an INC IR-100 [containing a 92.1 curie Iridium-192 source]. The source was retrieved and secured in the exposure device by trained personnel. Self reading pocket dosimeters for the radiographers and retriever involved indicate there were no overexposures as a result of this event. Dosimetry badges are being sent for processing. The licensee is re-inspecting and re-servicing all of its crank and cable assemblies. An investigation into this event is ongoing. More information will be provided as it is obtained in accordance with SA-300."

Texas Incident Number: 10063
Texas NMED Number: TX230049

AUXILIARY FEEDWATER SYSTEM INOPERABLE

The following information was provided by the licensee via email:

"On November 07, 2023 at 1200 EST, it was discovered that all pumps in the Auxiliary Feedwater system were inoperable due to the loss of control power to the 'B' train Emergency Feedwater (EFW) flow control valve which supplies the 'D' steam generator. The redundant 'A' train EFW control valve for the 'D' steam generator remains functional, as well as the capability of the Auxiliary Feedwater system to supply all steam generators.

"The"A" and "B" EFW Flow Control Valves are arranged in a series configuration for each Steam Generator. Failure of any of the 8 EFW Flow Control Valves to meet its Surveillance Requirements will render all EFW
Pumps inoperable per tech specs.

"This condition is being reported pursuant to 10 CFR 50.72(b)(3)(v)(B).

"The NRC Resident Inspector has been notified."

REACTOR TRIP DUE TO NON-SAFETY RELATED BUS UNDER VOLTAGE

The following information was provided by the licensee via email:

"At 1617 on 11/7/2023, Calvert Cliffs Unit 2 experienced an automatic trip from a Reactor Protection System (RPS) based on reactor trip bus under voltage (UV). At that time a loss of U-4000-22 caused a loss of 22, 23, and 24 4kV busses. This resulted in a loss of both motor generator (MG) sets causing the reactor trip bus UV condition. The loss of 22 and 23 4kV non-safety related busses resulted in a loss of main feedwater. Auxiliary feedwater (AFW) was manually initiated and is feeding both steam generators. The 2B diesel generator (DG) started and restored the 24 4kV safety related bus. Heat removal is via the normal turbine bypass valves to the main condenser.

"RPS actuation is reportable under 10 CFR 50.72(b)(2)(iv)(B) - 4-hour report.

"ESFAS actuation (2B DG start on UV) is reportable under 10CFR50.72(b)(3)(iv)(A) - 8-hour report.

"ESFAS actuation (AFW manual initiation) is reportable under 10CFR50.72(b)(3)(iv)(A) - 8-hour report.

"Site Senior NRC resident inspector has been notified."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
Unit 1 was unaffected. Estimation of duration of shutdown is 24 hours.