ENS 58085
ENS Event | |
|---|---|
05:00 Dec 12, 2025 | |
| Title | Medical Event |
| Event Description | The following information was provided by the PA Bureau of Radiation Protection (the Department) via email:
On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred. It is suspected that the cause was either the use of a third-party administration tubing set or a microcatheter defect, that caused a delay in administration leading to a clog in the line. The official cause is still under investigation. The Department will perform a reactive inspection. More information will be provided as received. PA event report ID number: PA250018 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.
The following additional information was provided by the PA Bureau of Radiation Protection (the Department) via email: On December 12, 2025, a patient was receiving 2 doses of Y-90 TheraSphere to 2 treatment sites. The prescribed dose was 131.08 mCi. The administration set was connected using the Boston Scientific checklist and all pre-checks, flushes, and priming were satisfactory with proper flow confirmed for the delivery kit and microcatheter. Issues developed as the first (larger) dose delivery initiated including leakage at the C-line, increased pressure, and excessive saline diversion to the pressure release vial. The RADOS dosimeter reduced by 93 percent, suggesting successful administration, however, subsequent 4-point measurements indicated a dose delivery of only 60.8 percent. It was determined that a 44.7 percent deviation between prescribed and administered dose occurred. The second smaller dose displayed the same issues with leakage and excess saline diversion but was administered with greater than 90 percent delivery. The patient received a dose of 72.4 mCi. The referring physician and the patient were notified. There was no adverse impact to the patient. It is suspected that the cause was the use of defective backup administration kits made by B. Braun, which were provided by Boston Scientific when the normal kits used at Thomas Jefferson University Hospital were unavailable due to backorder. The authorized user observed problems from the start of the administration including C-line clamp failure (requiring a hemostat to correct), increased pressure, and excess saline backflow to the pressure relief vial. An eventual obstruction occurred downstream after the dose vial and before the microcatheter, likely the clamp area between points 'D' and 'E' in the tubing. A high exposure rate was observed at this location (3.7 R/hr) while examining the waste materials supporting this location as having the obstruction. No other locations had exposure rates anywhere near this high. A second dose was administered to the same patient to a different treatment site in the liver using a fresh backup administration kit and the problem with the failed C-clamp and increased saline backflow repeated. In this case the dose was successfully delivered, likely because it was a much smaller dose (less beads, less chance of clumping up and obstructing the line in an environment of abnormal flow dynamics). The Department will perform a reactive inspection. More information will be provided as received. Notified R1DO (Carfang) and NMSS Events Notification (Email) |
| Where | |
|---|---|
| Thomas Jefferson University Hospitals Philadelphia, Pennsylvania (NRC Region 1) | |
| License number: | PA-0130 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+81.13 h3.38 days <br />0.483 weeks <br />0.111 months <br />) | |
| Opened: | John Chippo 14:08 Dec 15, 2025 |
| NRC Officer: | Ernest West |
| Last Updated: | Dec 19, 2025 |
| 58085 - NRC Website | |
Thomas Jefferson University Hospitals with Agreement State | |
WEEKMONTHYEARENS 580852025-12-12T05:00:00012 December 2025 05:00:00
[Table view]Agreement State Medical Event ENS 542302019-08-16T04:00:00016 August 2019 04:00:00 Agreement State Agreement State Report - Patient Under-Dosage ENS 497622014-01-22T05:00:00022 January 2014 05:00:00 Agreement State Pennsylvania Agreement State Report - Medical Underdose 2025-12-12T05:00:00 | |