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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 53971 | 2 April 2019 14:42:00 | Agreement State | Agreement State Report - Medical Event - Underdose Administration of Y-90 Microspheres | The following was received from the Commonwealth of Massachusetts via e-mail: On 4/2/19, 1430 EDT, the licensee reported a medical event involving Nordion TheraSpheres (SS&D NR-0220-D-131-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a two-vial Y-90 62 mCi (13 mCi and 49 mCi vials) microsphere therapy treatment delivered to the patient's liver on 4/2/19 was stuck in the catheter causing delivery of approximately 37 mCi Y-90. This was discovered immediately after treatment. The administered dose to the treatment area differed from the prescribed dose by approximately 40 percent. The licensee stated that the primary cause was an equipment malfunction. The first vial of 13 mCi was delivered fully, but only 24 mCi of the second vial containing 49 mCi was actually administered to the patient. The prescribing physician, referring physician and patient have been notified. The licensee stated that there were no negative health effects to the patient due to the situation. No additional Y-90 therapy treatment will be required. Corrective actions will include removal of the suspect equipment (catheter) and return of said equipment to the manufacturer for evaluation. A larger diameter catheter will be used during future therapy treatments. The licensee will submit a written report within 15 days of the discovery date. Agency on-site investigation is pending. This is a next day reportable medical event per regulations. Investigation ongoing. Agency considers this event docket to still be OPEN. 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 49881 | 5 March 2014 05:00:00 | Agreement State | Agreement State Report - Under Dose Involving Yttrium 90 Microspheres | The following information was received by email: On March 6, 2014, UMass Memorial Health Care (license number 60-0096) reported (to the Massachusetts Radiation Control Program) that on March 5, 2014 they had under dosed a patient by more than 20% using Y-90 microspheres. Further pertinent data is: Prescribed Activity: 26.4 mCi of Y-90 (in one fraction injection) Delivered Activity: 20.4 mCi of Y-90 (more than 20% different from prescribed) Resulting in: Prescribed Liver dose: = 32.6 Gy Delivered Liver dose: = 25.2 Gy Dose difference in organ: = 740 rads (i.e., greater than 50 rem and 20% difference) Note Also: Effective dose (requested): 32.6 Gy * 0.04 = 1.3 Sv Effective dose (delivered): 25.2 Gy * 0.04 = 1.0 Sv Effective dose difference: 1.3-1.0=0.3 Sv = 30 rem (greater than 5 rem difference) 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 45542 | 11 September 2009 05:00:00 | Agreement State | Agreement State Report- Potential Loss of Radioactive Material | The following information was received from the Commonwealth of Massachusetts via facsimile: On 9/11/09 a package containing 1 mCi of P-32 was received by the licensee Radiation Safety Office, (who then) opened the package to confirm RAM (radioactive material) was in the box, surveyed the package, and then delivered (the package) to the research lab. The research lab signed for the package. One week later the research lab reported to the RSO that the package did not contain the ordered P-32. A search of lab, adjacent labs, and waste removed from the lab did not locate the missing radioactive material. MA Docket Number: 10-8699 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source |