ENS Event | |
|---|---|
04:00 Sep 18, 2013 | |
| Title | Agreement State Report - Underdose To Patient'S Liver |
| Event Description | The Commonwealth of Massachusetts submitted the following information via email:
A dose that likely differs from the prescribed dose by more than 50 rem to an organ, the liver, and the total dose delivered differs from the prescribed dose by 20% or more. The licensee's radiation safety officer reported to the Agency [Massachusetts Radiation Control Program] on 9/18/2013 that on same date licensee administered yttrium-90 SIR-Spheres to patient's left lobe of liver for treatment of metastatic disease; that 16.8 millicuries of yttrium-90 was prescribed; and that 12.06 millicuries was administered resulting in an under dose of 28.1 percent. The licensee discovered the event upon measurement of waste material including dose vial as part of normal quality assurance. The licensee's radiation safety officer reported that the authorized user and the referring physician have been notified and it is unknown at time of the report whether the referring physician has elected to notify the patient. The licensee's radiation safety officer reported that medical staff does not believe that this error will adversely affect the patient treatment outcome. The licensee will submit a written report within 15 days in accordance with the [Massachusetts] requirements of 105 CMR 120.594(A)(4) to include why event occurred and actions to prevent recurrence. Root cause and corrective action are not known at this time and the Agency continues to investigate. System Name: Brachytherapy Product; Manufacturer: Sirtex Wilmington LLC 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 | |
|---|---|
| Massachusetts General Hospital Boston, Massachusetts (NRC Region 1) | |
| License number: | 60-0055 |
| Organization: | Ma Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+12.47 h0.52 days <br />0.0742 weeks <br />0.0171 months <br />) | |
| Opened: | Joshua Daehler 16:28 Sep 18, 2013 |
| NRC Officer: | Pete Snyder |
| Last Updated: | Sep 18, 2013 |
| 49354 - NRC Website | |
Massachusetts General Hospital with Agreement State | |
WEEKMONTHYEARENS 560292022-08-02T19:30:0002 August 2022 19:30:00
[Table view]Agreement State Underdose of Y-90 SIR-SPHERES ENS 542802019-09-11T04:00:00011 September 2019 04:00:00 Agreement State Agreement State Report - Misadministration of High Dose Rate Therapy ENS 498492014-02-19T05:00:00019 February 2014 05:00:00 Agreement State Agreement State Report - Underdose of Y-90 to a Patient ENS 493542013-09-18T04:00:00018 September 2013 04:00:00 Agreement State Agreement State Report - Underdose to Patient'S Liver ENS 465772011-01-13T05:00:00013 January 2011 05:00:00 Agreement State Agreement State Report - Potential Dose Exceeding Annual Occupational Dose Limit for Adults 2022-08-02T19:30:00 | |