ENS 52979
ENS Event | |
|---|---|
04:00 Aug 24, 2017 | |
| Title | Agreement State Report - Dose Delivered 20% Greater than Prescribed and Greater than 50 Rem to the Targeted Area |
| Event Description | The following information was received from the State of Georgia via email:
Emory University had new software installed for their HDR on 2/2/2016. During the time span of 3/2016 through 6/2017 [five] 5 patients received doses that were greater than 20% [percent] and greater than 50 rem to the targeted area. The misadministration was due to a software defect with Elekta's Oncentra Brachy Software version 4.5.2. using the ring applicator. The licensee was only aware of the defect on Aug 22, 2017 when Elekta notified all of their customers of the defect. Emory unofficially notified the State of Georgia on Aug 24, 2017 of a possibility that several of their patients may have been involved in a medical event. The medical event was confirmed on Sept 19, 2017 that [five] 5 patients were involved in a medical event. Cause and Corrective Actions: The events were due to a software issue utilizing the Oncentra Brachy Software version 4.5.2. A misadministration occurred due to an inconsistent step size when treating the ring source path. A source step size of 2.5 mm was planned. What was reported in the case explorer was a 5 mm step size. "Device/Associated Equipment: Oncentra Brachy Software version 4.5.2. in a Elekta Nucleotron MicroSelection v3 HDR using a ring applicator. The targeted area that received the greater than 50 rem was the tissue of the upper vaginal wall. The defect in the equipment is identified and described in EN#52922. 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 | |
|---|---|
| Emory University Atlanta, Georgia (NRC Region 1) | |
| License number: | GA 153-1 |
| Organization: | Georgia Radioactive Material Pgm |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+630.63 h26.276 days <br />3.754 weeks <br />0.864 months <br />) | |
| Opened: | Irene Bennett 10:38 Sep 19, 2017 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Sep 20, 2017 |
| 52979 - NRC Website | |
Emory University with Agreement State | |
WEEKMONTHYEARENS 569462024-02-01T05:00:0001 February 2024 05:00:00
[Table view]Agreement State Lost Source ENS 560072022-07-20T04:00:00020 July 2022 04:00:00 Agreement State Dose Misadministration ENS 558502022-04-11T04:00:00011 April 2022 04:00:00 Agreement State Lost/Missing Source ENS 549742020-10-29T04:00:00029 October 2020 04:00:00 Agreement State Dose Delivered Differs by Greater than 20 Percent ENS 549672020-10-23T04:00:00023 October 2020 04:00:00 Agreement State Dose Delivered Differs by Greater than 20 Percent ENS 534682018-06-21T04:00:00021 June 2018 04:00:00 Agreement State En Revision Imported Date 7/3/2018 ENS 529792017-08-24T04:00:00024 August 2017 04:00:00 Agreement State Agreement State Report - Dose Delivered 20% Greater than Prescribed and Greater than 50 Rem to the Targeted Area ENS 499172014-02-27T04:00:00027 February 2014 04:00:00 Agreement State Agreement State Report - Yttrium 90 Medical Event ENS 484412011-05-24T04:00:00024 May 2011 04:00:00 Agreement State Agreement State Report - Y-90 Therasphere Spill ENS 452462009-08-05T04:00:0005 August 2009 04:00:00 Agreement State Agreement State Report - Medical Dose Different than Prescribed ENS 443312008-05-31T04:00:00031 May 2008 04:00:00 Agreement State Agreement State - Possible Overexposure 2024-02-01T05:00:00 | |