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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 54840 | 18 August 2020 04:00:00 | Agreement State | Agreement State Report - Patient Underdose | The following report was received from the Ohio Department of Health via email. On August 14, 2020, the licensee attempted to treat a patient with Y-90 TheraSphere microspheres. Under the guidance of the manufacturer's representative, the AU (Authorized User) performed pre-patient checks on the device, including tubing patency check. After the infusion was started it became apparent the patient was not receiving the dose, and the licensee was unable to clear the blockage in the tubing. The procedure was terminated and the patient and referring physician were notified. Approximately 93% of the activity remained in the device. Static imaging was performed on the patient to determine the dose received. There was no measurable activity in the patient. Ohio Event No.: OH200004 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. |