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| Entered date | Event description | |
|---|---|---|
| ENS 57178 | 18 June 2024 12:46:00 | The following information was provided by the Arkansas Department of Health, Radiation Control, Radioactive Materials Program (the Agency) via email: The Agency was notified by the Radiation Safety Officer (RSO) for the University of Arkansas for Medical Sciences on Friday afternoon, June 7, 2024, to advise of a possible Y-90 TheraSphere misadministration where the patient did not receive all the prescribed dose. The administration was two doses to segment 5 of the patient's liver. The discovery was made when the tubing and waste from the procedure was surveyed after it was returned to the lab. The written report was received on Friday afternoon, June 14, 2024. On June 17, 2024, the Agency reviewed the information provided and determined that this event is a misadministration due to the following: The administered doses both differed from their respective prescribed doses by more than 0.5 Sv (50 rem) to an organ. The delivered dose of 95 Gy (9500 rem) was 198 Gy (19800 rem) less than the (prescribed) dose of 293 Gy (29300 rem) for dose number one; the delivered dose of 105 Gy (10500 rem) was 21 Gy (2100 rem) less than the (prescribed) dose of 126 Gy (12600 rem) for dose number two. (For) dose number one only, the total dose delivered differs from the prescribed dose by twenty percent or more. Dose number one was outside the treatment prescription range; 68 percent of the prescribed dose was not received. Therefore, (dose) number one is considered to be a misadministration in accordance with current emerging medical technology licensing guidance. Dose number two was just inside the treatment prescription range; 17 percent of the prescribed dose was not received. The referring physician and (the) patient were notified, and the patient has been scheduled for an additional treatment. The investigation is ongoing, and reporting will proceed in accordance with SA-300. Arkansas Event number: AR-2024-004 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. |