ENS Event | |
|---|---|
19:00 May 24, 2023 | |
| Title | Patient Underdose |
| Event Description | The following information was provided by the Colorado Department of Health via email:
On May 24, 2023, the Radiation Safety Officer of the University of Colorado Hospital (RAML [Radioactive Material License] 828-01) reported a medical event. The medical event occurred during the administration of Y-90 TheraSphere treatment that took place in the afternoon on Wednesday, May 24, 2023. During the administration, there appeared to be an obstruction in the catheter's line preventing the target from receiving the intended dose. The obstruction was noticed early in the procedure and it's estimated only 5 to10 percent of dose went to the target organ. After the obstruction was observed, the catheter was removed from the patient and the rest of the dose was not administered. This event is similar to an event at the same hospital on May 18, 2023 (CO230012) which occurred with a different AU [authorized user]. The TheraSpheres were from the same batch. The licensee is pausing Therasphere administrations from the same lot number. We are still waiting on additional information from the hospital about the investigation. Event Report ID No.: CO230014 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 Colorado Hospital Aurora, Colorado (NRC Region 4) | |
| License number: | CO 828-01 |
| Organization: | Colorado Dept Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+21.67 h0.903 days <br />0.129 weeks <br />0.0297 months <br />) | |
| Opened: | Heather Gilbert 16:40 May 25, 2023 |
| NRC Officer: | Ian Howard |
| Last Updated: | May 25, 2023 |
| 56540 - NRC Website | |
University Of Colorado Hospital with Agreement State | |
WEEKMONTHYEARENS 567772023-10-04T06:00:0004 October 2023 06:00:00
[Table view]Agreement State Medical Underdose ENS 565402023-05-24T19:00:00024 May 2023 19:00:00 Agreement State Patient Underdose ENS 565292023-05-18T06:00:00018 May 2023 06:00:00 Agreement State Medical Event (Patient Underdose) ENS 551112021-02-22T19:30:00022 February 2021 19:30:00 Agreement State Lutetium-177 in Stolen Vehicle Recovered ENS 541932019-08-01T21:30:0001 August 2019 21:30:00 Agreement State Agreement State Report - Possible Lost Radioactive Material ENS 528512017-07-12T17:00:00012 July 2017 17:00:00 Agreement State Agreement State Report - Misadministration of Treatment ENS 514702015-10-14T20:30:00014 October 2015 20:30:00 Agreement State Colorado Agreement State Report - Patient Received 40 Percent Less than Prescribed Dose ENS 470432011-07-08T13:30:0008 July 2011 13:30:00 Agreement State Agreement State Report - Medical Event Overexposure to Thyroid Gland 2023-05-24T19:00:00 | |