ENS Event | |
|---|---|
18:14 Sep 16, 2011 | |
| Title | |
| Event Description | The following information was received from the Commonwealth of Pennsylvania via facsimile:
Event Type: A medical event (ME) involving Y-90 Theraspheres where the patient received 51% of the intended dose, which is reportable under 10CFR35.3045(a)(1)(ii). 'Notifications: On September 16, 2011, at 1414 [EDT], the Department's Southeast Regional Office received notification via phone message about the ME. Event Description. The patient was being treated with MDS Nordion Y-90 glass Theraspheres for transarterial radioembolization. A suspected defective catheter caused 49% of the intended dose to clog up in the catheter. No harm to the patient is expected. The referring physician and patient have been notified. No more information is available at this time. Cause of the event: The cause of the event is suspected to be a defective catheter. Actions: After decay, the catheter will be returned to Nordion for inspection and may also be returned to the manufacturer, Terumo Medical, for a defect analysis. The licensee will be submitting a written report within 15 days. The [Pennsylvania] Department [of Environmental Protection] plans to do a reactive inspection. PA Report ID: PA110025 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. |
| Where | |
|---|---|
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania (NRC Region 1) | |
| License number: | PA-0130 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+88.22 h3.676 days <br />0.525 weeks <br />0.121 months <br />) | |
| Opened: | Joe Melnic 10:27 Sep 20, 2011 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Sep 20, 2011 |
| 47281 - NRC Website | |
Thomas Jefferson University Hospital with Agreement State | |
WEEKMONTHYEARENS 527092017-04-25T04:00:00025 April 2017 04:00:00
[Table view]Agreement State Agreement State Report - Medical Event Due to Underdose of Yittrium-90 Theraspheres ENS 520932016-07-13T04:00:00013 July 2016 04:00:00 Agreement State Agreement State Report - Underdose Medical Event ENS 477712012-03-22T04:00:00022 March 2012 04:00:00 Agreement State Agreement State Report - Patient Received Less than Intended Dose ENS 476122012-01-20T19:09:00020 January 2012 19:09:00 Agreement State Agreement State Report - Misadministration of Dose to Patient ENS 472812011-09-16T18:14:00016 September 2011 18:14:00 Agreement State Agreement State Report - Medical Event Involving Y-90 Therasphere Underdose 2017-04-25T04:00:00 | |