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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 415796 April 2005 05:00:0010 CFR 21.21, Notification of failure to comply or existence of a defect and its evaluation10 Cfr Part 21 Report Involving Potential Defect in an High Dose Rate Afterloading DeviceLankenau Hospital reported an incident involving a Nucletron V2 microselectron High Dose Rate Afterloading device. The Hospital reports that a source stuck in a GYN transfer tube during quality operational checks. The source had to be manually retracted with a hand crank back into a safe position. Inspection of the GYN tube revealed a restriction (described as an edge) that developed on the end that connects to the treatment unit. The Hospital report states that the tube had been in use for two years and may have developed the restriction from normal wear and tear. The tube was replaced and the defective tube transferred to Nucletron. The Hospital report notes that normal wire transfer checks (without the source present) did not identify the problem - but probably should have. The Hospital report also stated that the restriction should not have prevent the source from being automatically retracted to its safe location once the emergency stop was actuated. The cause of the GYN tube restriction is unknown.
ENS 473856 October 2011 04:00:00Agreement StateAgreement State Report - Fetus Exposed to Radiation During Thyroid Therapy TreatmentThe following was received from the state via facsimile: The patient took a pregnancy test on October 5, 2011 and the results were negative. The patient was then treated with 73.7mCi of I-131 thyroid therapy treatment on October 6, 2011. The patient discovered she was pregnant and contacted the licensee on October 26, 2011. The estimated dose to the fetus is 17.4 Rads. It has been determined that the fetus was 10 days old when the therapy was given to the patient. The licensee will be submitting a written report within 15 days. The Department plans to do a reactive inspection to review licensee's procedures and response to this ME. Event Report ID No. PA110031