Event Notification Report for August 04, 2025

EN Revision Imported Date: 8/4/2025

EN Revision Text: 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

* * * UPDATE ON AUGUST 1, 2025 AT 1544 EDT FROM GARY FORSEE TO JON LILLIENDAHL * * *

The following update was provided by the Illinois Emergency Management Agency via email:

"On May 22, 2025, the manufacturer provided their assessment. They suspect the cause of the event was low flow rate (which allows the microspheres to fall from suspension), possibly due to kinks observed in the microcatheter. Absent the availability of additional data, this matter is considered closed."

Notified R3DO (Hills) and NMSS Events Notification (email)

AGREEMENT STATE REPORT - DAMAGED TROXLER GAUGE

The following information was provided by the Maryland Department of the Environment (MDE) via email:

"On July 25, 2025, at approximately 1520 EDT, the radiation safety officer (RSO) of Engineering Consulting Services Mid-Atlantic, LLC (ECS) reported an incident to MDE involving damage to a Troxler model 3440 portable nuclear gauge (serial number 30580). The incident occurred at a construction site located in Frederick, MD.

"According to the gauge technician, the roller operator initially passed the technician on the right side and then reversed the roller toward the testing site. Despite immediate attempts to alert the driver to stop, the roller continued reversing. Once the gauge operator realized the driver was not stopping, he quickly moved out of the roller's path. The gauge was subsequently struck by the roller.

"As reported by the RSO, while the gauge housing was damaged, there is no indication of a breach of the radioactive sources' integrity. The RSO conducted leak tests immediately after the incident and submitted the samples to North East Technical Services Inc. (NETS) for analysis. Results are currently pending. MDE has requested the licensee to transfer the damaged gauge to NETS as per the safety protocol and provide the leak test results, calibration records, and appropriate transfer and/or disposal documentation once the evaluation by NETS is complete. Decisions regarding repair or disposal of the gauge will be based on NETS' findings.

"Following removal of the gauge from the site, a radiation survey was conducted, and no elevated radiation levels above background were detected as per the RSO. MDE's radiological health program will continue to monitor and follow up on this reactive investigation until the device is either repaired or appropriately disposed of."

UNANALYZED CONDITION

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

"The facility is in a safe and stable configuration. Additionally, the facility is not [and] has never been in a flooded state, and no accident has occurred.

"Urenco USA has stored three end-of-life uranium hexafluoride traps in the ventilated room on the first floor of the cylinder receipt and dispatch building (CRDB). These traps were previously installed in the system on the second floor of the process services corridor (PSC). While installed, these traps have been analyzed as safe for movement and interaction without any external controls.

"Flooding is not considered a credible event for the second floor of the PSC. However, these traps have been moved to the first floor of the CRDB for storage where flooding is a credible event. A first-floor condition of flooding with the traps has not been modeled in the nuclear criticality safety analysis (NCSA).

"The storage of traps in the first-floor ventilated room potentially falls outside of the normal operating conditions analyzed in NCSA and integrated safety analysis (ISA) related documentation and results in the facility being in a state that was different from analyzed in the ISA.

"Corrective actions have begun."

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

Personnel access to the area has been restricted pending completion of the evaluation.

AGREEMENT STATE REPORT - MEDICAL EVENT

The following information was provided by the Florida Bureau of Radiation Control (BRC) via email:

"BRC was notified on 7/28/25 that on Friday, 7/25/25, a patient at Advent Health, Daytona was receiving Y-90 TheraSphere treatment for the liver. The patient received a dose which differed by more than 20 percent from the prescribed dose. Treatment was provided in 2 segments, denoted in 2 scripts. One segment received the full prescribed treatment, while the other segment received 51 percent of the intended treatment. Due to the treatment being provided as 2 scripts, treatment two differed by more than 20 percent.

"The [licensee's] radiation safety officer states that the dosimeter on the vial showed a dose of 0, but when all administration materials were removed, the residual within the equipment was much higher than expected. The primary care provider has been informed. It is unknown if the patient has been informed."

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.

POTENTIAL INOPERABILITY OF RESIDUAL HEAT REMOVAL (RHR) SYSTEM

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

"At 1645 CDT on July 30, 2025, it was discovered that the single train of the ultimate heat sink was inoperable. Due to this inoperability, the system was in a condition that could have prevented the fulfillment of a safety function; therefore, this condition is being reported as an eight-hour, non-emergency notification per 10 CFR 50.72(b)(3)(v)(B).

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

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

The proximal cause of the inoperability was due to a buildup of grasses in the crib house from the river. Operators were able to clear the crib house bar rack intake and restore operability within eight minutes.

BOTH TRAINS OF CONTROL ROOM EMERGENCY VENTILATION/CONTROL ROOM EMERGENCY TEMPERATURE SYSTEM INOPERABLE

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

"At 1744 EDT, on 7/31/2025, it was discovered both trains of control room emergency ventilation (CREVS) and control room emergency temperature system (CRETS) were simultaneously inoperable due to a damper going shut in the control room ventilation system. The damper went back to its normal open position in less than a minute. Due to this inoperability, the system was in a condition that could have prevented the fulfillment of a safety function; therefore, this condition is being reported as an eight-hour, non-emergency notification per 10 CFR 50.72(b)(3)(v)(D). There was no impact on the health and safety of the public or plant personnel. The NRC Resident Inspector has been notified."

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

Multiple technical specification limiting conditions for operation (LCOs) such as LCO 3.0.3, 3.7.8, and 3.7.9 were entered as a result of this event.

AUTOMATIC REACTOR SCRAM

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

"On 8/1/2025, at 2350 CDT, Browns Ferry Unit 1 experienced an automatic scram due to low reactor water level. A low reactor water level of `+2' inches resulted in a valid actuation of the reactor protection system which caused all of the rods to insert. During the scram response, there was a valid actuation of the primary containment isolations systems groups 2, 3, 6 and 8. Upon receipt of these signals, all components actuated as required. Following the scram, reactor water level lowered below the '-45' inches setpoint, actuating high pressure coolant injection and reactor core isolation coolant and tripped both reactor recirculation pumps as required. Operations responded and stabilized the plant. Reactor water level is being maintained via the condensate system. Decay heat is being removed by bypass valves to the main condenser. There was no impact on Units 2 and 3.

"This event requires a 4-hour non-emergency report per 10 CFR 50.72(b)(2)(iv)(B), any event or condition that results in actuation of the reactor protection system when the reactor is critical except when the actuation results from and is part of a pre-planned sequence during testing or reactor operation.

"This event requires a 4-hour non-emergency report per 10 CFR 50.72(b)(2)(iv)(A), any event that results or should have resulted in emergency core cooling system (ECCS) discharge into the reactor coolant system as a result of a valid signal except when the actuation results from and is part of a pre-planned sequence during testing or reactor operation.

"This event requires an 8-hour non-emergency report per 10 CFR 50.72(b)(3)(iv)(A), any event or condition that results in valid actuation of any of the systems listed in paragraph (b)(3)(iv)(B): 1) Reactor protection system including: reactor scram or reactor trip. 2) General containment isolation signals affecting containment isolation valves in more than one system or multiple main steam isolation valves (MSIVs).

"All safety systems operated as expected. At no time were public health and safety at risk. The NRC Resident Inspector has been notified."