The following information was received from
Illinois Emergency Management Agency (Agency) via E-mail:
Agency inspectors performed a routine inspection on 1/6/2022. During a review of Y-90 TheraSphere procedures, inspectors noted an unreported medical event which occurred on 2/15/2021.
On 2/15/2021, a written directive to deliver 1.93 GBq Y-90 TheraSpheres to the right hepatic artery was prepared. The procedure performed that same day was halted prematurely due to an unwinding of the male luer lock connector and only 0.49 GBq were administered. To compensate for the underdose, the licensee created an additional written directive and administered 1.17 GBq Y-90 TheraSpheres without incident [on the same day as the initial procedure].
The licensee was under the impression that this was not a reportable medical event since they were able to compensate the dose with an additional vial they had on hand and were ultimately able to deliver the intended dose.
Item Number: IL220001
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.