ENS 54815
ENS Event | |
|---|---|
05:00 Aug 3, 2020 | |
| Title | Agreement State Report - Patient Underdose |
| Event Description | The following information was received from the Texas Department of State Health Services (the Agency) via email:
On August 4, 2020, the Agency was notified by the licensee's radiation safety officer (RSO) that an event occurred during the administration of Y-90 TheraSpheres on August 3, 2020. The RSO stated the written directive prescribed dosage was 22.3 mCi. During the administration of the TheraSpheres, the pressure observed by the Authorized User (AU) became significantly less than expected, and activity leaving the dose administration vial into the catheter decreased significantly before the entire dose could be delivered. The RSO stated a TheraSpheres (Boston Scientific) representative was present during the procedure and assisted the authorized user through troubleshooting, and remote consultation with TheraSpheres medical specialists. However, flow from the dose administration vial could not be re-initiated. The AU chose to end the procedure. Following survey of the dose administration vial in the hot lab, it was determined that approximately 7.1 mCi (31.8 percent) was delivered to the patient. The RSO stated that their initial assessment is that this was the result of a device malfunction. There were no adverse effects to the patient. It is likely that a second procedure will be scheduled to complete the procedure. The RSO stated that the patient and referring physician were notified. This is the first event involving TheraSpheres reported to the Agency by this licensee. The RSO stated additional information on the event will be provided within the next 10 days. Additional information will be provided as it is received by the Agency in accordance with SA-300. Texas Incident Number: 9782 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 | |
|---|---|
| Texas Dept Of State Health Services Dallas, Texas (NRC Region 4) | |
| License number: | L 00659 |
| Organization: | Texas Dept Of State Health Services |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+40.35 h1.681 days <br />0.24 weeks <br />0.0553 months <br />) | |
| Opened: | Arthur Tucker 21:21 Aug 4, 2020 |
| NRC Officer: | Andrew Waugh |
| Last Updated: | Aug 4, 2020 |
| 54815 - NRC Website | |
Texas Department of State Health Services with Agreement State | |||||||
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