ENS Event | |
|---|---|
05:00 Aug 28, 2012 | |
| Title | Agreement State Report - Medical Event Involving Y-90 Sir-Spheres |
| Event Description | The following information was obtained from the Commonwealth of Pennsylvania via email and facsimile:
Notifications: On February 13, 2013 the licensee informed the Department's [Pennsylvania Department of Environmental Protection] South-central Regional Office of the medical event. The event is reportable within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> per 10 CFR 35.3045(a)(1)(i). The referring physician was notified of this event but the patient passed away in November of 2012 as a result of metastatic pancreatic cancer. Event Description: During a routine audit of the Y-90 written directive program, an error was noted in a SIR-Sphere procedure that was performed on August 28, 2012. The patient was prescribed 17.6 mCi of Y-90 SIR-Spheres. The patient actually received only 12.8 mCi. This corresponds to a dose that is 27.3% lower than the prescribed dose. Cause of the Event: The physician recorded the wrong administered dose on the written directive form. Also a small liquid volume remained in the vial after the 'air-injection' final step. Actions: The licensee initiated and completed an audit of all SIR-Sphere procedures and no other issues were identified in any other patients since inception of the program. The South-central Regional Office has been in discussion with the licensee regarding corrective actions that will be implemented. Pennsylvania Event Report ID No.: PA130006 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 | |
|---|---|
| Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania (NRC Region 1) | |
| License number: | Pa-0127 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+4088.47 h170.353 days <br />24.336 weeks <br />5.6 months <br />) | |
| Opened: | Joe Melnic 14:28 Feb 14, 2013 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Feb 14, 2013 |
| 48752 - NRC Website | |
Penn State Milton S. Hershey Medical Center with Agreement State | |
WEEKMONTHYEARENS 487522012-08-28T05:00:00028 August 2012 05:00:00
[Table view]Agreement State Agreement State Report - Medical Event Involving Y-90 Sir-Spheres 2012-08-28T05:00:00 | |