ENS Event | |
|---|---|
19:50 Nov 2, 2011 | |
| Title | Agreement State Report - Underdosage of Y-90 Theraspheres |
| Event Description | The following was received from the Commonwealth of Pennsylvania via fax:
Event type: A medical event (ME) involving Y-90 TheraSpheres where the patient received an under-dose of 63%, which is reportable under 10CFR35.3045(a)(1)(ii). Notifications: On November 2, 2011, at 1550, the Department's Southeast Regional Office received notification via phone message about the ME. Event Description: A patient who was being treated with MDS Nordion Y-90 TheraSpheres, received only 37% of the intended dose based on the before and after survey readings of the TheraSphere accoutrements (5.8mR/hr vs. 3.8mR/hr). The licensee is in the process of notifying the patient. No more information is available at this time. Cause of the Event: The licensee suspects that procedural changes led to the problem. Nordion recently changed the procedure to clamp the priming line with a hemostat because the original clamp is hard to manipulate. This was their first procedure using the hemostat. Actions: Nordion has been contacted. The licensee will be submitting a written report within 15 days. The Department plans to do a reactive inspection. Event Report ID No. PA 110033 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 | |
|---|---|
| Eastern Regional Medical Center Philadelphia, Pennsylvania (NRC Region 1) | |
| License number: | PA-0980 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+14.65 h0.61 days <br />0.0872 weeks <br />0.0201 months <br />) | |
| Opened: | Joe Melnic 10:29 Nov 3, 2011 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Nov 3, 2011 |
| 47404 - NRC Website | |
Eastern Regional Medical Center with Agreement State | |
WEEKMONTHYEARENS 538682019-02-08T05:00:0008 February 2019 05:00:00
[Table view]Agreement State Agreement State Report - Delivered Dose to Patient Less than Prescribed Dose ENS 474042011-11-02T19:50:0002 November 2011 19:50:00 Agreement State Agreement State Report - Underdosage of Y-90 Theraspheres ENS 465672011-01-19T05:00:00019 January 2011 05:00:00 Agreement State Agreement State Report - Potential Dosage Different than Intended Dose 2019-02-08T05:00:00 | |