ENS Event | |
|---|---|
05:00 Dec 11, 2009 | |
| Title | Agreement State Report - Medical Event |
| Event Description | The following information was obtained from the Commonwealth of Pennsylvania via facsimile:
Medi-Physics [PA license PA-0515] prepared a 30 ml kit of Myoview at approximately 2:30 a.m. on December 11, 2009. The radiochemical purity was determined to be 91%. They consider 90% on the center as passing. On December 11, 2009, Grand View Hospital reported a problem with a nuclear medicine scan. Medi-Physics confirmed with BRP [Pennsylvania Bureau of Radiation Protection] that they dispensed 50 doses from the vial of Myoview in question. They believed 13 of these doses were administered to patients in PA and NJ. They thought the doses that were administered were resting doses of 8 to 10 mCi each. They assured BRP that they have a system in place to track their doses and contacted all the recipients once they were notified of the problem. Initially, Grand View, one of the hospitals that received a Myoview dose, called Medi-Physics to advise them they saw thyroid and no cardiac uptake in a patient they injected with Myoview. This suggests free 99mTC04. Therefore, at approximately 8:30 a.m., they repeated [the quality check] on the Myoview left in the vial and determined the tag was less than 1%. Medi-Physics is still investigating the problem and will send the vial to the United Kingdom for chemical analysis once it is no longer radioactive. BRP feels this is an [abnormal occurrence] because there was (fundamentally) the wrong radiopharmaceutical given to a patient. BRP has been in contact with all parties, will continue to investigate and enter in NMED. PA Report ID No.: PA090035
The following information was obtained from the Commonwealth of Pennsylvania via facsimile: Retraction of A.O. [abnormal occurrence]. Licensee calculations note patient dose below reporting / A.O. criteria. There will be no external NMED report. 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 | |
|---|---|
| Grand View Hospital Sellersville, Pennsylvania (NRC Region 1) | |
| License number: | PA-0220 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+13.67 h0.57 days <br />0.0814 weeks <br />0.0187 months <br />) | |
| Opened: | David Allard 18:40 Dec 11, 2009 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Feb 23, 2010 |
| 45563 - NRC Website | |
Grand View Hospital with Agreement State | |
WEEKMONTHYEARENS 455632009-12-11T05:00:00011 December 2009 05:00:00
[Table view]Agreement State Agreement State Report - Medical Event 2009-12-11T05:00:00 | |