Semantic search
| Entered date | Event description | |
|---|---|---|
| ENS 52922 | 24 August 2017 06:53:00 | The following is excerpted from a report received from the Georgia Department of Natural Resources: On August 8th, a patient was undergoing a gynecological treatment using a ring applicator with the microSelectron HDR utilizing Oncentra Brachy Software version 4.5.2. On the 2nd of a 4 fraction treatment of ring and tandem, a mistreatment occurred due to 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. This plan was sent to the TCS (Treatment Control System) and delivered at a 5 mm steps size. It was intended to treat specific areas, but the delivered areas were 2.5 mm - 60 mm different than intended. This was confirmed using gafchromic film on a QA plan after treatment was completed. This event was reported by the State of Mississippi - see related EN 52914. Elekta identified that this issue occurs when using Applicator Models with a measured source path in combination with a specific afterloader configuration, as follows: Oncentra Brachy - Version 4.5, 4.5.1, 4.5.2, Applicator Modeling with a measured source path, RDStore default step size 5.0 mm, 10.0 mm Afterloader - microSelectron HDR/PDR V2, V3/Digital Applicators - Ring Applicator Sets, Ring CT/MR Applicator sets, Interstitial CT/MR Rings, Vienna CT/MR Rings, Advanced Gynecological Applicator - Venezia with Lunar-shaped ovoids In Elekta bulletin (IFSN 806-01-BTP-001) the Ring applicator will be used to represent all applicable applicators. Where ring is mentioned also lunar-shaped ovoids apply (Advanced Gynecological Applicator). Where 5.0 mm is used as a default step size this could also be 10.0 mm. Oncentra Brachy incorrectly handles the placement of the ring applicator models with the measured source path in combination with the microSelectron treatment unit, for which the default step size differs from 2.5 mm. Three other facilities previously reported this issue and the manufacturer had started working on a bug fix and field notification. All other cases found the issue during QA, so no patients were involved. Veenendaal has put a stop to the delivery of the Applicator Modeling until the Oncentra Brachy v 4.5.3 is released. An Important Field Safety Notification was sent to all customers concerning the use of ring source paths with applicator modeling on 8/11/17 (IFSN 806-01-BTP-001 attached). An Oncentra Brachy patch is in process to fix this safety issue. |
| ENS 52882 | 2 August 2017 14:51:00 | The following is excerpted from a report emailed from the Georgia Radioactive Materials Program: On 7/26/17, two Ir-192 Elekta sources (each approximately 11.2 Ci) were shipped from Alpha-Omega Services in Vinton, LA, via a common carrier with two different destination points. They made it to the common carrier's warehouse in Memphis, TN, but then were "lost." An investigation for both cases has been opened with the common carrier and the common carrier point of contact has been notified via email. The packages were expected on 7/28/17 at their respective destinations. Serial number 31016 to UPMC Altoona in Altoona, PA and serial number 10729 to Arrowhead Radiation & Oncology Imaging Center in Glendale, AZ.
The following is excerpted from an email from the Georgia Radioactive Materials Program: Georgia is requesting retraction of the Georgia NMED Report of 8/2/17. The two sources referenced therein were never lost. Notified R1DO (Bickett), R4DO (Gepford), NMSS Events Notification and CNSNS (Mexico) by email. THIS MATERIAL EVENT CONTAINS A "CATEGORY 3" LEVEL OF RADIOACTIVE MATERIAL Category 3 sources, if not safely managed or securely protected, could cause permanent injury to a person who handled them, or were otherwise in contact with them, for some hours. It could possibly - although it is unlikely - be fatal to be close to this amount of unshielded radioactive material for a period of days to weeks. These sources are typically used in practices such as fixed industrial gauges involving high activity sources (for example: level gauges, dredger gauges, conveyor gauges and spinning pipe gauges) and well logging. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf |