Event Notification Report for February 01, 2024

EN Revision Imported Date: 2/1/2024

EN Revision Text: AGREEMENT STATE REPORT - Y-90 MICROSPHERE MISADMINISTRATION

The following is a summary of information received via email from the Washington Office of Radiation Protection:

On the afternoon of Friday, January 19th, a Pluvicto (radiopharmaceutical) dose was not administered properly. A typical administered dose may have up to 2 to 4 mCi of residual activity after a 200 mCi administration. However, for this administration there was 43 mCi of residual activity and only 149 mCi of calculated administered activity for a 200 mCi prescribed dose. Pluvicto is a six fraction, six administration regimen with about six weeks between each administration, and this was the patient's fourth fractional dose. Treated as a single administration treatment, this constitutes a medical event as the dose administered activity of 149 mCi is more than 20% less than the 200 mCi prescribed dose. The final report will be sent in 15 days.

Washington Event Number: WA-24-003

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.

* * * UPDATE ON 1/29/2024 AT 1401 EST FROM BORIS TSENOV TO NATALIE STARFISH * * *
The following information is a synopsis of information provided by the Washington State Radioactive Materials Section:

A lutetium 177 (drug name: Pluvicto) dose was prescribed to be 200 mCi. The calculated dose administered to the patient was about 149 mCi, based upon the measured residual. The underdosing occurred due to a method of folding and crimping the intravenous tube with a hemostat and gauze instead of utilizing the kit provided clamp. The hospital supply chain of the intravenous kit was recently changed and the needed clamp was thought to be missing. To prevent future crimping of the intravenous tube, the use of hemostat and gauze will no longer be used.

This dose was the fourth dose of six prescribed to the patient, with six weeks between each administration. There is no expected change in the patient's treatment or prognosis based on the underdosing of the fourth fraction of six and no additional actions are required.

Final report will be sent in 15 days.

Washington Event Number: WA-24-003

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.

Notified R4DO (Agrawal) and NMSS (email).

AGREEMENT STATE REPORT - UNDERDOSE CAUSED BY EQUIPMENT FAILURE

The following information was provided by the Wisconsin Radiation Protection Section via email:

"On January 25, 2024, the licensee reported a medical event at 1119 CST which had occurred the same day at 0900 CST, where the dose delivered for a single fraction differed from the prescribed dose by more than 50 percent. This event is also reportable as an equipment failure. A patient was being treated with a Nucletron Corporation Model 106.990 high dose rate remote after loader unit, and during the fraction, the physicist noticed that the timer on the console had frozen while the source remained exposed. The planned treatment time was 6 minutes and 15 seconds over 9 dwell positions, and the timer, counting down, was frozen at 6 minutes and 7 seconds. Once the freeze was noticed, the physicist pressed the emergency stop button on the console to terminate the treatment. The physicist estimated that the total treatment time was approximately 30-40 seconds, all of which was to the first dwell position. The authorized user had prescribed 550 cGy for this fraction and the physicist estimated that only 11 percent of the prescribed dose was delivered. The physicist reported that the timer functioned properly during the daily quality assurance checks prior to treatment. The patient and patient's family were notified by the authorized user. The licensee is contacting the device vendor for emergency service."

Wisconsin Event Number: WI240001

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.

FITNESS FOR DUTY

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

On January 30, 2024, a non-licensed employee supervisor, after investigation, was determined to be in involved with a controlled substance. The employee's access to the site has been placed on administrative hold, pending further investigation.

The NRC Resident Inspector has been notified.