ENS 56847
ENS Event | |
|---|---|
22:00 Nov 9, 2023 | |
| Title | Patient Received 45 Percent Underdose |
| Event Description | The following was received from the South Carolina Department of Health and Environmental Control (Department) via phone and email:
The South Carolina Department of Health and Environmental Control was notified via telephone at approximately 0930 EST on 11/10/23 that a medical event had been discovered by the licensee on 11/09/23 at approximately 1700 EST. The Medical University of South Carolina (MUSC) reported an underdose to a patient's liver during a Y-90 microsphere procedure by 45 percent of the prescribed 500 Gray (Gy) dose. MUSC estimates that the patient received 276 Gy of the intended 500 Gy dose. The licensee reported that the total dose or activity delivered differs from the prescribed dose or activity, as documented in the written directive, by 20 percent or more. The licensee reports no immediate or ongoing concerns to public health and safety. Department inspectors will be dispatched to the facility to investigate this event. This event is still under investigation by the South Carolina Department of Health and Environmental Control. 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.
The following update was received from the South Carolina Department of Health and Environmental Control (Department) via phone and email: The licensee provided their 15-day written report dated 11/17/23, which was received on 11/18/23. The written report indicated that at the time of the Y-90 radioembolization procedure no leaking was present, and after three flushes were performed the dose vial (originally containing the TheraSpheres) was measured again. Surveys of the vial and procedure room indicated radiation doses to be at background levels. Additionally, the licensee reported that measurements of the Nalgene container contents demonstrated high levels of residual activity and based on these readings the licensee ascertained that 55 percent of the prescribed dose was administered to the patient. Upon further investigation, the licensee stated that the microcatheter passing through the Y-fitting ruptured allowing the TheraSpheres to escape and collect in the fitting. The licensee's corrective actions included: communicating the details of this event with the manufacturer and inquire on whether this event has previously occurred, and requested from the manufacturer to provide refresher training to staff on the set-up of administration lines. Finally, the licensee reported that no adverse effects to the patient are expected to occur as a result of this event, since only 55 percent of the intended dose was delivered. Department inspectors were dispatched to the facility on 12/06/23. The details of the event were consistent with the licensee's 15-day written report. This event and investigation are considered closed. Notified R1DO (Ford) and NMSS Events Notification via email. |
| Where | |
|---|---|
| Medical University Hospital Charleston, South Carolina (NRC Region 1) | |
| License number: | 081 |
| Organization: | Sc Dept Of Health & Env Control |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+12.03 h0.501 days <br />0.0716 weeks <br />0.0165 months <br />) | |
| Opened: | Korina Koci 10:02 Nov 10, 2023 |
| NRC Officer: | Eric Simpson |
| Last Updated: | Mar 19, 2024 |
| 56847 - NRC Website | |
Medical University Hospital with Agreement State | |
WEEKMONTHYEARENS 568472023-11-09T22:00:0009 November 2023 22:00:00
[Table view]Agreement State Patient Received 45 Percent Underdose 2023-11-09T22:00:00 | |