Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 52914 | 18 August 2017 05:00:00 | Agreement State | Agreement State Report - Patient Underdose | The following report was received via e-mail: The licensee's RSO reported a possible medical event for four separate patients, involving a Nucletron Model microSelectron-HDR 106.990 remote afterloading brachytherapy unit. This was noticed during review by the medical physicist. The licensee notified Elekta for confirmation of the software error. The RSO confirmed on 8/18/2017, that two (2) patients were under dosed by more than 20% and the other two (2) patients were being reviewed by the medical physicist. An Elekta Notification was sent out to all MS Radioactive Licensees on 8/17/2017, that possess a Nucletron Model microSelectron-HDR. Source: 12 Ci, Ir-192, Elekta Model 105.002 Mississippi Report: MS-170002
Update: 10/18/2017 Licensee reported four (4) medical events utilizing the tandem and ring applicator model within Elekta's Oncentra Brachy Software version 4.5.2. Licensee written report received, 8/23/2017, for the period between 11/8/2016 and 8/15/2017, stated two of the four patients treated using Nucletron Model microSelectron-HDR 106.990 remote afterloading brachytherapy unit and utilizing the tandem and ring applicator model within Oncentra's Treatment Planning software received a dose less than 20% of the prescribed dose to the treatment site (base of the uterus). All of the treated patients received greater than 50 Rem and 50 percent or more of the dose expected from the administration to unintended tissue (vaginal canal). The written directives called for a prescribed dose of 28 Gy for three patients and 27 Gy for one patient, to be delivered in four (4) separate fractions to the base of the uterus. All four (4) fractions were affected for one patient, three (3) fractions for two patients, and only one (1) fraction for one patient, which received 50 percent or more of the dose expected from the administration. Patient / Estimated Dose Delivered to Treatment Site / Percent of Intended Dose from Written Directive / Affected Number of Fractions / Expected Range of Doses to Unintended tissue / Estimated Dose to Unintended Tissue Patient A / 18.44 Gy / 65.84 % / 4 / 126 cGy and 175 cGy per treatment fraction / > 28 Gy Patient B / 21.78 Gy / 77.7 % / 3 / 126 cGy and 175 cGy per treatment fraction / > 7 Gy per fraction (total > 21 Gy) Patient C / 23.39 Gy / 83.55 % / 3 / 126 cGy and 175 cGy per treatment fraction / > 7 Gy per fraction (total > 21 Gy) Patient D / 26.84 Gy / 99.41 % / 1 / 126 cGy and 175 cGy per treatment fraction / > 14 Gy for one fraction A software error occurs in the Oncentra Treatment Planning Software version 4.5.2, whenever the built-in tandem and ring applicator model is used. The microSelection afterloader step size of a measured source path is 2.5 mm. An override to the default step size of 5 mm (RDStore), from the step size of the measured source path in the planning software occurred. A change in the source position step size, from 2.5 mm to 5 mm was not realized by the licensee for the ring catheter but was implemented for the delivery plan. The dose distribution, prescription point values, and dose volume histogram readouts were all based on a 5 mm spaced tandem and a 2.5 mm spaced ring. When the plans were exported to the treatment unit and delivered, the afterloading brachytherapy unit utilized a source step size of 5 mm for both the tandem and ring applicators, thus a discrepancy between the planned and delivered dose distributions occurred. The licensee has suspended use of the tandem and ring applicator model within the software and will define all catheters for the tandem and ring applicator manually until further notice of Elekta's software correction. The referring physician and patients have been notified. No adverse health effects were noted for the patients due to the medical events. Activity: 12 Ci Licensee Authorization Update: (8.85 Ci - 5.195 Ci) Date of Incident: 11/8/2016 through 8/15/2017 List any other actions required of DRH (Mississippi Division of Rad Health): Licensee notified to send 15-day written report. Elekta Notification, FCA-NU-0004, FCO Reference No. 806-01-BTP-001, was sent out to all MS Radioactive Licensees on 8/17/2017, that possess a Nucletron Model microSelectron-HDR. Licensee's written report received August 23, 2017. DRH conducted a reactive inspection of the licensee on September 1, 2017, to determine the cause and further clarify the medical events. The medical events were discussed with the licensee's RSO's, medical physicist(s), and the chair of Radiation Oncology on September 1, 2017, and again on October 17, 2017 and October 18, 2017, with the licensee's medical physicist. Case Closed: Yes Date Closed: 10/19/2017 Notified R4DO (Vasquez) and NMSS Events Notification 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. | ||
| ENS 44577 | 9 October 2008 05:00:00 | Agreement State | Agreement State Report - 50 Percent Underadministration of Yttrium-90 | The state provided in the following information via e-mail: On 10/10/08, licensee's RSO notified DRH (Division of Radiological Health) of a Yttrium-90 SIR-Spheres medical event. The reportable event involved the administration of 54 mCi of SIR-Spheres for one patient with approximately 27 mCi instilled into both the right and left hepatic arteries. After instilling approximately 27 mCi of Yttrium-90 SIR Spheres based on radiation readings into the right hepatic artery, a smaller catheter for the left hepatic artery was used due to anatomy and to get to the segment feeding the tumor. While attempting to instill the Yttrium-90 SIR Spheres into the left hepatic artery over-pressurization caused the three (3) way valve in the containment box to give way and resulted in the release of a therapeutic dose of Yttrium-90 SIR Spheres into the delivery system containment box as per design. Due to the release of the second part of the dose into the containment box only approximately 50% of the dose was able to be administered. The procedure was terminated and the delivery box was bagged and held for decay-in-storage. Personnel in the room were monitored for contamination and the room was surveyed and released. The patient was released with no harmful effects foreseeable by the Radiation Oncologist. The patient and referring physician were notified of additional future treatment. Licensee suggested the incident may have been caused by the size of the catheter, a kink in the catheter, or a smaller syringe being used by the interventional radiologist putting increased pressure on the 3 way valve. As a result of the medical event the licensee's treatment team will review the delivery system setup before pressure is applied to ensure the flow of the SIR-Spheres will not be impeded within the catheter. License No.: MS-MBL-01 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. | ||
| ENS 44137 | 11 December 2007 05:00:00 | Agreement State | Agreement State Report - Mississippi - Misadministration Involving an Hdr Treatment | The State provided the following information via email: On 3-26-08, licensee's RSO notified DRH (Mississippi Division of Radiation Health) of a Iridium-192 HDR treatment misadministration. The reportable event involves the administration of 3 separate fractions for one (1) patient over a six (6) day period. The misadministration was caused by not measuring the catheters. Measurements taken on 3-25-08 of the tandem and ovoid applicators connected to the Varion Varisource HDR indicated that the length of the source wire entered in the treatment planning system should be 128 cm instead of 120 cm. Further inspection of the catheters revealed that the ovoid catheters were correct but the tandem catheter should have been used with a different applicator. The error resulted in the dose being delivered approximately 86 mm inferior to the desired location. The prescribed treatment was for 5 fractional treatments for 600 cGy each (3000 cGy total); however, due to the error only 470 cGy was administered in 3 treatments (26% of the prescribed dose). It was noted during the investigation by DRH that for other problems not associated with the HDR treatments, the patient did not return for the final 2 fractional doses. The dose to the vaginal region inferior to the treatment area received a 1300 cGy overexposure as a result of the error. The Radiation Oncologist does not foresee this patient experiencing adverse health effects as a result of this misadministration. The referring physician and the patient have been notified. MS Report No. MS-08004 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. |