ENS 50074
ENS Event | |
|---|---|
04:00 Apr 24, 2014 | |
| Title | Agreement State Report - Second Scheduled Medical Dose Not Delivered Due To Equipment Failure |
| Event Description | The following information was provided by the State of Virginia via facsimile:
On April 24, 2014, the licensee performed a two part therapy procedure using yttrium-90 microspheres (Sirtex SirSpheres). The procedure was to treat the same lobe of the liver via two different arterial pathways. There were no problems with the first injection, but the second injection failed and none of the yttrium-90 was delivered to the patient. The licensee determined that the failure occurred because of a faulty Surefire Medical catheter. The authorized user decided not to repeat the administration of the second dose but will treat the region with an alternate method. The licensee indicated that the prescribed dosage for the first injection was 11.7 millicuries and that 12.7 millicuries (27,500 rem to the target region of the loft lobe) was delivered. The prescribed dosage for the second injection was 8.3 millicuries (to give a dose of 26,200 rem to the targeted region) but no activity was delivered. This resulted in a medical event for the second injection (or fraction) as well as for the entire procedure. VA Event Report ID No.: VA-2014-003
The following information was provided by the Commonwealth of Virginia via facsimile: The licensee submitted a written report on May 9, 2014, which contained additional information from its review of the event. The licensee's review concluded that the failure of the catheter (Surefire Medical, Model SHF-38120-mT) during the second procedure was attributable a kink or fold in a basket on the catheter which resulted in a catheter occlusion. The licensee concluded that the short arterial segment used for the arterial pathway and the acute angle at the arterial origin, along with possible manipulation or patient movement, resulted in a kink or fold as the basket entered the acute angle of the artery. The catheter will be returned after decay of the radioactivity to the manufacturer for examination. The licensee submitted corrective actions for the procedure which include retraining of personnel to use extra care in ensuring the catheter is firmly set and to flush the catheter prior to administration of the microspheres to ensure there is no occlusion. The agency will review implementation of the corrective actions during a future inspection. Notified R1DO (Lilliendahl) and FSME Events Resource via email. 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 | |
|---|---|
| Sentara Norfolk General Hospital Norfolk, Virginia (NRC Region 1) | |
| License number: | 710-189-1 |
| Organization: | Virginia Rad Materials Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+155.43 h6.476 days <br />0.925 weeks <br />0.213 months <br />) | |
| Opened: | Charles Coleman 15:26 Apr 30, 2014 |
| NRC Officer: | Jeff Rotton |
| Last Updated: | May 9, 2014 |
| 50074 - NRC Website | |
Sentara Norfolk General Hospital with Agreement State | |
WEEKMONTHYEARENS 556172021-11-30T05:00:00030 November 2021 05:00:00
[Table view]Agreement State Underdose of Patient Medical Event ENS 500742014-04-24T04:00:00024 April 2014 04:00:00 Agreement State Agreement State Report - Second Scheduled Medical Dose Not Delivered Due to Equipment Failure 2021-11-30T05:00:00 | |