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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 53011 | 12 October 2017 15:05:00 | Agreement State | Agreement State Report - Dose Delivered Less than Prescribed | The following information was received from the State of Ohio via email: On 10/12/17 during an infusion of Y-90 SIRSpheres that began at 11:05 a.m. (EDT), the treatment device malfunctioned and ceased delivery of the radioisotope, resulting in an under-dosing of the patient's liver. No contamination of the facilities or personnel was detected. All activity that was not delivered into the patient was placed back into the acrylic box and secured in the nuclear medicine hot lab for decay. A SIRSpheres representative was present during the treatment, but the cause of the malfunction is not known at this time. Once sufficient decay of the radioisotope has occurred, the delivery device will be shipped to SIRSpheres for technical analysis and root cause determination. The patient was informed on the day of the event. Ohio Item Number: OH170006 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. |