ENS 49849
ENS Event | |
|---|---|
05:00 Feb 19, 2014 | |
| Title | |
| Event Description | The following information was obtained from the Commonwealth of Massachusetts via email:
Report of medical event. A dose that 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 reported to the Agency [Massachusetts Radiation Control Program] on 2/21/2014 that on 2/19/2014 licensee administered yttrium-90 SIR-Spheres to patient's left lobe of liver and that treatment was palliative in nature; that 7.2 millicuries of yttrium-90 was prescribed; and that 5.06 millicuries was administered resulting in an underdose of 29.7 percent. The licensee reported that the dose administered differs from the dose prescribed by more than 50 rem to the liver and that licensee will determine what the likely dose difference actually was. The licensee reported that during the procedure it was apparent that spheres were collecting on the tubing between the stop cock and the source vial and that when procedure was concluded, assays were performed of treatment apparatus and source vial and licensee determined that only 5.06 millicuries of the 7.2 millicuries prescribed was administered. The licensee reported that the manufacturer, Sirtex, will be onsite on February 24th to begin a joint investigation. The licensee reported that the referring physician has been notified and it is unknown at time of report whether referring physician has elected to notify patient. The licensee reported that they do not anticipate any adverse effects on the patient's treatment outcome. The licensee will submit a written report within 15 days in accordance with the requirements of 105 CMR 120.594(A)(4). Root cause and corrective action are not known at this time and the Massachusetts Radiation Control Program continues to investigate. 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:+59.47 h2.478 days <br />0.354 weeks <br />0.0815 months <br />) | |
| Opened: | Joshua Daehler 16:28 Feb 21, 2014 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Feb 21, 2014 |
| 49849 - 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 | |