Event Notification Report for October 21, 2024

AGREEMENT STATE REPORT - PATIENT UNDERDOSE

The following information was provided by the Pennsylvania Bureau of Radiation Protection (the Bureau) via email:

"On October 10, 2024, the licensee informed the Bureau of a medical event involving a treatment with TheraSpheres. It is reportable per 10 CFR 35.3045.

"On October 9, 2024, a patient was receiving a [Y-90] TheraSphere treatment. Only 32.7 percent of the prescribed activity (15.975 mCi) was administered to the patient. The physician and the patient were informed on October 9, 2024, following the treatment.

"It is suspected that the cause was an occlusion within the catheter which prevented the proper flow of fluid and TheraSpheres into the patient. The official cause is still under investigation.

"The Bureau will perform a reactive inspection. More information will be provided as received."

Pennsylvania Event Report ID: PA240019

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.

LOST SOURCE

The following is a summary of information provided by the National Oceanic and Atmospheric Administration (NOAA) via phone:

A current authorized user was on site in August to test and calibrate systems. They verbally notified the radiation safety officer (RSO) on August 26, 2024, that the spare Ni-63 electron capture detector (ECD) was not in the respective gas chromatograph (GC) which is normally located in the sea-going CFC van. On August 27, the authorized user and the RSO began a search for the missing ECD. The RSO contacted the previous authorized user on August 27, 2024, and they reported that they did not recall reinstalling the spare ECD in March 2020 due to the cruise being cancelled due to COVID. On September 1st, 2024, that authorized user sent a photo of the box used for shipping the ECD, noting that the photo was from July 14, 2021, and the box was present in the sea-going van in Seattle, Washington. A further search was conducted in the sea-going van by the RSO, and the other authorized user, but the ECD and the shipping box have not been located. This search was suspended on October 10, 2024. The licensee will continue looking for the missing ECD.

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:

Device Information:
Manufacturer: Shimadzu
Model: GC-8A
Source S/N: 2191
Activity: 8.3 mCi

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 - THERASPHERE DEVICE FAILURE

The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:

"The Agency was contacted on October 10, 2024, by Northwestern Memorial Healthcare in Chicago, IL, to advise of a suspected TheraSphere device failure. There was no associated medical event, nor any contamination resulting from the equipment failure.

"Reportedly, on September 23, 2024, during the administration of Y-90 TheraSpheres, the treatment was immediately halted by the authorized user (AU) following infusion of 3 mL of saline through the system due to observation of excessive air bubbles present in the outlet line. Both the [authorized medical physicist] (AMP) and the AU noticed what appeared to be flakes in the bottom of the 'V' vial and possible microspheres in the outlet line. The source vial and attached microcatheter were removed following standard procedures. The licensee followed the standard protocol and determined that the patient received 42.18 Gy of the prescribed 45.48 Gy. No follow up or medical action was required of the patient. No contamination of staff, patient, or the area was identified. Staff were interviewed to determine possible causes of the leak, with no deviations from the protocol noted. No initial defects in the administration kit were noted, however, after concluding their investigation, the licensee made the determination of a reportable equipment failure on October 9, 2024. The investigation remains ongoing, and a report was sent by the licensee to the manufacturer on October 9, 2024. This matter is reportable under 32 Illinois Administrative Code 340.1220(c)(2)."

NMED number: IL240023

AGREEMENT STATE REPORT - SOURCE DISCONNECT

The following report was received via phone and email from the Texas Department of State Health Services (the Department):

"On October 13, 2024, the Department was notified by the licensee's radiation safety officer (RSO) that on October 12, 2024, one of their crew had experienced a source disconnect while using a QSA 880D exposure device. The device contained a 38 curie (RSO estimate) iridium-192 source. The disconnect occurred when the connector on the QSA manufactured drive cable separated from the drive cable. The exposure device had been suspended about 25 feet in the air to shoot a weld in a pipe rack. When the radiographers retracted the source after the first shoot, they noted that the dose rate readings on their survey meter were high. They cranked the source back out and attempted to retract the source a second time, but the readings remained high. They cranked the source out again, reset their radiation boundary, and contacted their RSO. The RSO responded to the site and was able to attach the source to a new drive cable and retract the source to the fully shielded position. The RSO stated that as soon as they completed their investigation, they will send the crank outs to the manufacturer for inspection. The RSO stated that no individual exceeded any exposure limit but will send the exposure badges for all personnel involved for processing. Additional information will be provided as it is received in accordance with SA-300."

Texas Incident Number: 10135
NMED Number: TX240035

60-DAY OPTIONAL TELEPHONIC NOTIFICATION OF INVALID ACTUATION OF CONTAINMENT ISOLATION VALVES

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

"This 60-day optional telephone notification is being made in lieu of a licensee event report (LER) submittal as allowed by 10 CFR 50.73(a)(1). This notification is made pursuant to the reporting requirements specified in 10 CFR 50.73(a)(2)(iv)(A) for an invalid actuation of one of the systems listed in 10 CFR 50.73(a)(2)(iv)(B).

"At approximately 1342 EDT, on September 10, 2024, the reactor water cleanup (RWCU) inboard primary containment isolation valve (PCIV), and the reactor recirculation pump sample inboard PCIV, unexpectedly closed. At the time of this event, work was in progress replacing a control relay in the residual heat removal (RHR) shutdown cooling inboard isolation PCIV circuitry. This relay replacement required lifting the leads of several wires. The neutral side of the relay was electrically connected with the actuation logic for the inboard RWCU and reactor recirculation pump sample PCIVs; the lifting of this lead resulted in the unexpected closure of these PCIVs.

"The actuation was not initiated in response to actual plant conditions, nor an intentional manual initiation, and there were no parameters satisfying the requirements for initiation of the system. Therefore, this event has been determined to be an invalid actuation.

"During this event the PCIVs functioned successfully, and the actuations were complete. This event did not result in any adverse impact to the health and safety of the public.

"The NRC Resident Inspector was notified."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
Unit 2 was not affected.

CONCURRENT REPORT - FIRE DOOR MALFUNCTION

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

"At approximately 1600 EDT, on October 16, 2024, the New Hanover county deputy fire marshal was notified that a non-IROFS (item relied on for safety) fire door was damaged and incapable of fulfilling its function. Specifically, the door would not latch properly and stay fully closed. A fire watch was initiated and repairs started. The door latch was repaired and returned to full operation at 0730, on October 17, 2024. The fire marshal was informed and the fire watch terminated. Because the New Hanover county deputy fire marshal was notified, a concurrent notification to the NRC Headquarters Operations Center is being made per 10 CFR 70, Appendix A(c).

"The NRC region will be notified."