ENS Event | |
|---|---|
04:00 Jul 13, 2016 | |
| Title | Agreement State Report - Underdose Medical Event |
| Event Description | The following was received via email:
Event Description: A patient was undergoing a Y-90 Therasphere procedure in two separate treatments (to different liver segments). The delivery kits for both administrations passed the standard pre-administration testing. The physician and team noted no other equipment related issues until the administering Interventional Radiologist Physician noted unusual resistance during the first actual administration. After unsuccessful attempts to 'clear the line,' the efforts to complete the administration were terminated. The team then attempted to treat a second site, with essentially the same sequence of events occurring. Both delivery sets came from the same manufacturing lot, and both dosages of Theraspheres came from the same drug lot. The licensee estimates approximately 25 percent of the written directive dose was delivered. Cause of the Event: Unknown at this time. It is worth noting, another Theraspheres administration on another patient was performed the following day without incident. The delivery system kits were again from the same lot as those used on the previous day, but the Therasphere dosage was from a different lot. Actions: Licensee notified Nordion of the occurrence. The Department [PA Department of Environmental Protection] will perform a reactive inspection next week. Event Report ID: PA160019 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:+58.6 h2.442 days <br />0.349 weeks <br />0.0803 months <br />) | |
| Opened: | Joseph Melnic 14:36 Jul 15, 2016 |
| NRC Officer: | Dong Park |
| Last Updated: | Jul 15, 2016 |
| 52093 - 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 | |