ENS 45727
ENS Event | |
|---|---|
05:00 Jan 21, 2010 | |
| Title | Agreement State Report - Brachytherapy Implants Outside Of The Intended Treatment Area |
| Event Description | The following information was received via fax:
Notifications: The licensee called the PaDEP Southeast Regional Office on the morning of February 25, 2010 to provide a 24-hour verbal notice of a possible Medical Event. The SERO and Central Office discussed the known facts around noon time, and understood the U Penn RSO would be providing more information via email. DEP also provided a verbal notice to NRC Region 1 regarding this possible ME on 2-25-2010. On January 21, 2010 a patient was treated by brachytherapy for prostate cancer with sixty five (65) iodine-125 (I-125) seeds. The I-125 seeds were implanted using real time dosimetry under ultrasonic guidance. The written directive called for a therapeutic radiation dose of 145 gray (Gy) [14,500 rad] to the prostate volume, plus 5 millimeters of margin, using interoperative planning. On February 23, 2010, the patient returned for a 30 day post-implant CT. The scan showed that the implanted seeds were "in an appropriate pattern," but outside the intended target. On February 24th the licensee's Radiation Oncology group determined that an additional quality assurance review was warranted, but the RSO should notify PaDEP/BRP [Pennsylvania Department of Environmental Protection/Bureau of Radiation Protection] regarding the case. Based on the information known at this time, PaDEP/BRP believes this ME is reportable under 10CFR35.3045, and may be an Abnormal Occurrence (AO). The state will perform a reactive inspection next week, and coordinate with NRC Region I; because of their ongoing evaluation of pre-April 2008 brachytherapy implants at U Penn, and at the Philadelphia VA hospital. Cause of the event: A new ultrasound unit that was used to place the I-125 seeds may have been malfunctioning. Actions: There is a reactive inspection scheduled to investigate this apparent ME at U Penn on March 2, 2010. PaDEP/BRP will also ask U Penn to evaluate the need for FDA notification regarding the ultrasound unit. Event Report ID Number: PA100002 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 | |
|---|---|
| University Of Pennsylvania Philadelphia, Pennsylvania (NRC Region 1) | |
| License number: | Pa-0131 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+853.9 h35.579 days <br />5.083 weeks <br />1.17 months <br />) | |
| Opened: | David J. Allard 18:54 Feb 25, 2010 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Feb 25, 2010 |
| 45727 - NRC Website
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University of Pennsylvania with Agreement State | |
WEEKMONTHYEARENS 570812024-04-17T04:00:00017 April 2024 04:00:00
[Table view]Agreement State Medical Underdose ENS 566612023-08-05T15:07:0005 August 2023 15:07:00 Agreement State Medical Underdose ENS 570862023-01-31T04:00:00031 January 2023 04:00:00 Agreement State Medical Event ENS 570852022-12-29T04:00:00029 December 2022 04:00:00 Agreement State Medical Event ENS 570842022-12-28T04:00:00028 December 2022 04:00:00 Agreement State Medical Event ENS 558892022-05-04T04:00:0004 May 2022 04:00:00 Agreement State Underdose ENS 558512022-04-18T04:00:00018 April 2022 04:00:00 Agreement State Patient Underdose ENS 553372021-07-02T04:00:0002 July 2021 04:00:00 Agreement State Patient Under Dose ENS 549642020-10-20T04:00:00020 October 2020 04:00:00 Agreement State Missing Licensed Material ENS 534302018-05-25T04:00:00025 May 2018 04:00:00 Agreement State En Revision Imported Date 10/15/2018 ENS 525042017-01-19T05:00:00019 January 2017 05:00:00 Agreement State Agreement State Report - Received Dose Less than Prescribed Dose ENS 524572016-12-20T05:00:00020 December 2016 05:00:00 Agreement State Agreement State Report - Medical Underdose ENS 483032012-09-11T04:00:00011 September 2012 04:00:00 Agreement State Agreement State Report - Patient Underexposure Using Yttrium-90 Sir-Spheres Treatment ENS 482292012-08-23T04:00:00023 August 2012 04:00:00 Agreement State Agreement State Report - Patient Underexposure Using Yttrium-90 Sir-Spheres Treatment ENS 481372012-07-26T04:00:00026 July 2012 04:00:00 Agreement State Agreement State Report - Medical Event Involving an Underdose with Yttrium-90 Spheres ENS 477632012-03-20T04:00:00020 March 2012 04:00:00 Agreement State Agreement State Report - Underdose During Liver Disease Treatment ENS 474352011-11-10T12:00:00010 November 2011 12:00:00 Agreement State Agreement State Report - Underdosage of Theraspheres ENS 461012010-07-07T04:00:0007 July 2010 04:00:00 Agreement State Agreement State Report - Delivered Dose Differed from the Prescribed Dose by Greater than 50% ENS 457272010-01-21T05:00:00021 January 2010 05:00:00 Agreement State Agreement State Report - Brachytherapy Implants Outside of the Intended Treatment Area 2024-04-17T04:00:00 | |