ENS 47057
ENS Event | |
|---|---|
04:00 Jul 12, 2011 | |
| Title | Agreement State Report - Medical Event Involving Treatment Dose Administered To Wrong Site |
| Event Description | The following event report was received from the Pennsylvania Bureau of Radiation Protection:
The licensee called the PA Department of Environment Protection (PaDEP) Southeast Regional Office at 1050 EDT on July 14, 2011 to provide a 24-hour verbal notice of a Medical Event (ME). A total treatment dose was administered to the wrong site, consequently requiring a 24-hour report per 10 CFR 35.3045(a)(3). This event also meets the criteria for Abnormal Occurrence (AO) reporting. On July 12, 2011 a Yttrium-90 (Y-90) SIR-Sphere treatment was performed. The written directive was for treatment of the liver's right lobe, but the total treatment was delivered to the left lobe. The prescribed dose was 31.5 millicurie (mCi) of Y-90. There are several open questions regarding root cause, potential health impact on the patient and communications to the patient and their physician. PaDEP/BRP will be performing a reactive inspection, which is scheduled for Monday July 18, 2011. Updates to this NRC report will be made once we investigate the ME at Lehigh Valley Health Network and obtain the follow-up written report from the licensee. PA report Number: PA110016
The State of Pennsylvania is retracting this report based on the following: After a PaDEP reactive inspection on July 28, 2011 and discussion with the licensee regarding the circumstances of a SirSphere infusion performed on July 12, 2011, it was determined a Medical Event [and Abnormal Occurrence) did not occur. The licensee's report concludes that there was no medical event because the authorized user intended to treat a lesion in the right lobe of the liver and that was what happened. The interventional radiologist who performed the procedure elected to use the left hepatic artery because a prior treatment through the right hepatic artery was unsuccessful in treating this lesion. The interventional radiologist and the authorized user discussed this at the time of the treatment and were in full agreement on the procedure. Medical Event should be retracted; no further action to be taken at this time. Notified R1DO (Bellamy) and FSME (McKenney). 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 | |
|---|---|
| Lehigh Valley Health Network Pennsylvania (NRC Region 1) | |
| License number: | Pa-0232 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+79.55 h3.315 days <br />0.474 weeks <br />0.109 months <br />) | |
| Opened: | David Allard 11:33 Jul 15, 2011 |
| NRC Officer: | Bill Huffman |
| Last Updated: | Aug 2, 2011 |
| 47057 - NRC Website | |
Lehigh Valley Health Network with Agreement State | |
WEEKMONTHYEARENS 543762019-11-05T05:00:0005 November 2019 05:00:00
[Table view]Agreement State En Revision Imported Date 11/20/2019 ENS 470572011-07-12T04:00:00012 July 2011 04:00:00 Agreement State Agreement State Report - Medical Event Involving Treatment Dose Administered to Wrong Site 2019-11-05T05:00:00 | |