Event Notification Report for January 03, 2024

EN Revision Imported Date: 1/3/2024

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL UNDERDOSE

The following information was provided by the Kentucky Department for Public Health and Safety, Radiation Health Branch (KY RHB) via email:

"KY RHB was notified on 8/30/2023, at 1700 CDT, by a representative from University of Kentucky Broadscope Medical, of an underdose of a patient during a lutetium 177 (Lu-177) treatment. The underdosing was due to a leakage in the administration line.

"The underdosing was considered more than 20 percent. There was no harm to the patient. A separate report will be submitted once all the facts are gathered."

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 FROM RUSSELL HESTAND TO BRIAN P. SMITH AT 1229 EST ON JANUARY 2, 2024 * * *

The following summary of information was provided by the Kentucky Department of Public Health and Safety, Radiation Health Branch (KY RHB) via email and phone:

Further pertinent information regarding the medical event on Wednesday, August 30, 2023 at Chandler Hospital was identified per KY RHB's 15 day report. The event involved an administration of 200 mCi of Lutathera (Lu-177) via syringe pump where a leak was identified during the infusion. At approximately 20 minutes into the infusion the patient reported a wet feeling on their hand. The infusion was halted immediately. It was identified that a small volume of radioactive liquid was present on the patient's hand having dripped down onto it. The site of the leak was identified to be the connection between the syringe pump apparatus and the patient. Bedding and materials adjacent to the patient were found to have absorbed the majority of the leaked material, though some had also leaked onto the floor coverings. Spill response procedures were immediately initiated as well as notification to the authorized user (AU). Approximately 1/3 of the prescribed activity remained in the syringe. The AU elected to have a new connection established and administer the remainder to the patient.

The licensee estimated the administered activity based on volume of the drug administered, measurements of the contaminated bedding materials, and patient dose rate measurements post infusion (corrected for BMI). These estimates all suggest that this incident resulted in an underdose of approximately 25 percent to 30 percent due to the lost material from the leak. The skin dose to the patient's hand was estimated to conservatively be less than 10 rem (100 mSv). This is well below the level at which any tissue reaction is expected to occur.

Notified R1DO (Bickett), NMSS (Rivera-Capella), NMSS Events Notification (email)

NMED Event Number: 230360