Event Notification Report for January 27, 2023

AGREEMENT STATE REPORT - PATIENT UNDERDOSE

The following is a summary of information provided by the Washington State Department of Health (DOH), Radioactive Materials Section via email:

The licensee reported that a Y-90 TheraSphere liver treatment was completed in accordance with manufacturer requirements and nothing out of the ordinary was observed. However, during a subsequent step to flush the system with saline, the technician, who is not an authorized user or radioactive material user, noticed bubbles coming up above the vial. Wipe samples of the procedure equipment were counted and showed radioactivity. A second flush of the system was initiated but the same bubbles were observed and therefore the flush was stopped, and the catheter was retracted from the patient. Additional flushes were not attempted. An evaluation showed that the patient received only 33 percent of the intended dose. The activity contained in the wipes and cleaning materials accounted for the balance of the intended dose (66 percent) and was disposed of as waste. DOH has requested additional information regarding potential occupational exposures. The licensee will submit a detailed report.

Washington Incident Number: WA-23-003.

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 MEDICAL EVENT

The following is a summary of information provided by the licensee via email and phone:

A patient, accompanied by her daughter who is the patient's preferred translator, was receiving the first of four Lutathera infusions. The physician, registered nurse, nuclear medicine personnel and radiological safety team members were present for the infusion. The Lutathera infusion was performed per protocol without any issue. Post infusion it was determined through the patient's daughter that the patient had had a lanreotide injection last week on 1/12/23. Per protocol Lutathera is to be given four weeks after a lanreotide/octreotide injection has been administered.

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 REPORT - PATIENT UNDERDOSE

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

"On January 20, 2023 the licensee informed the Department of an under-dose incident involving yttrium-90 (Y-90) TheraSpheres. It is reportable per 10 CFR 35.3045(a)(1).

"On January 11, 2023 an Authorized User (AU) in Interventional Radiology was attempting to treat a patient with 45.4 mCi of yttrium-90 TheraSphere. The AU could not get the spheres to infuse. After consultation with the manufacturer (Boston Scientific), they decided on aborting the procedure. It was determined the patient received zero activity and all the radioactivity from the spheres remained inside the treatment vial. The patient and referring physician have been informed. The Department is currently in contact with the licensee and will update this event as soon as more information is provided."

Event Report ID No: PA230005

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.

EN Revision Imported Date: 1/27/2023

EN Revision Text: PART 21 - MEDIUM VOLTAGE CIRCUIT BREAKERS

The following information is a synopsis of information provided by the licensee via fax and phone:

On May 23, 2022, Framatome informed Tennessee Valley Authority (TVA) of a deviation of breakers purchased under contract. On January 23, 2023, TVA determined that a defect of the basic component could create a substantial safety hazard.

Framatome Inc. identified a deviation in the Siemens medium voltage vacuum circuit breaker where a failure to electrically charge or electrically close could occur. Framatome Inc. identified this as a departure from the technical requirements included in the procurement document. It is noted that the ability to electrically trip the circuit breaker would not be affected by the condition. TVA was notified by Framatome under 10 CFR 21.21(b) to evaluate the application of the breaker for a substantial safety hazard.

The TVA evaluation identified these breakers as intended for use in safety related Class 1E applications where a loss of the closure function would impact mitigation of design basis accidents and transients. During the Framatome dedication testing/inspection of Siemens medium voltage vacuum breakers, a hi-pot test failure on one circuit breaker was encountered. Troubleshooting and inspection found damage to charging motor wiring. It was determined that the cause of the damage was due to the manner in which control wiring was routed and connected to the internal bracket in close proximity to a bracket edge. This edge caused damage to wiring after significant number of cycles were applied to the breaker prior to dedication testing.

TVA received nine medium voltage vacuum circuit breakers at an offsite warehouse facility. While located at that facility, TVA, with assistance from Framatome, examined the affected breakers for the wire routing condition. The wiring harnesses of certain breakers were corrected. Framatome is to examine medium voltage vacuum circuit breakers that may be purchased under this contract for the wiring condition and correct as necessary before delivery.

The NRC Senior Resident Inspector has been notified.

This is a non-emergency notification required by 10 CFR 21.21(d)(3)(i).

* * * UPDATE ON 1/26/23 AT 0916 EST FROM RICARDO MEDINA TO BRIAN P. SMITH * * *

The following information is a synopsis of information provided by the licensee via phone:

The Sequoyah site licensing manager requested via phone call to the HOO that the model number for the basic component with the defect be listed in the Part 21 event narrative in addition to the official Part 21 report. The component discussed is a Siemens 6.9kV, 1200A, 125VDC Vacuum Circuit Breaker, Model No.: 7-HKR-50-1200-130.

Notified R2DO (Miller) and the Part 21 Reactors Group (Email).