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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5467216 April 2020 04:00:0010 CFR 35.3045(a)(1)Underdose to PatientThe following is a summary of information received via telephone: On April 16, 2020, a patient received 11.5 percent of the prescribed dose of Y-90 TheraSphere therapy to the left liver. It is believed that the delivery device malfunctioned as the technician experienced increased pressure in the line when pushing the TheraSphere into the caster. The therapy was aborted after a few failed attempts. The intended dose was 97.3 milliCuries of Y-90. The patient is aware and will be returning for the remainder of the dose. The licensee contacted the vendor who will discard the malfunctioned device. 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.