ENS 47404

v t e 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.

ENS 47404 +/-
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
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Eastern Regional Medical Center with Agreement State
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