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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5369525 October 2018 04:00:0010 CFR 35.3045(a)(1)Medical Event - UnderdoseA patient was prescribed 200 mCi of Lutetium-177. Due to dose administration issues, a delivered dose of 135 mCi was received by the patient. The licensee notified the NRC Region 3 contact (Gattone). 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.
ENS 4794617 May 2012 12:00:0010 CFR 35.3045(a)(1)Medical Event - Patient Injected with Wrong Radiopharmaceutical and QuantityA patient scheduled for a lymphoscintigraphy procedure was incorrectly injected with 25 milliCuries of Tc-99M Medronate instead of the prescribed 3 milliCuries of Tc-99 Sulphur Colloid. The cause of the event was human error. The patient and physician have been notified. The physician believes there will be no long term adverse effects due to this error. In order to prevent reoccurrence, the nuclear medicine staff will add this event to staff training to ensure that staff double check the label and the dosage and drug. Other options are still being assessed. The licensee also notified NRC Region 3 (Bob Gattone). 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.
ENS 466659 March 2011 15:00:0010 CFR 35.3045(a)(1)Medical Event Involving Administration of Greater than Ordered DoseAn Authorized User physician from the University of Michigan Department of Radiation Oncology planned two liver infusion treatments for a patient with unresectable hepatocellular carcinoma using Y-90 Theraspheres. As part of treatment preparation, an MRI was performed on the patient to determine the patient's liver segment volumes. Liver segment volumes are used in calculating the Y-90 activity needed to deliver the prescribed radiation dose to particular segments of the liver. The first treatment was to the right lobe and medial segment of the patient's liver and was performed on 12/15/2010. It proceeded without incident and in accordance with the written directive. The Authorized User physician scheduled a second separate treatment to the patient's left lobe to be performed on 3/9/2011. The Authorized User ordered a 74.4 Gy dose to the left lobe of the liver. The medical physicist calculated a corresponding dosage of 60.5 mCi of Y-90 to be infused into the left lobe of the liver. However, in arriving at the Y-90 activity needed, a medical physicist used the liver segment volumes for the right lobe and medial segment combined instead of that for the left lobe. The volume of the right lobe and medial segment is much larger than that for the left lobe. As a result, the Y-90 dosage of 60.5 mCi exceeded what was actually needed to deliver the prescribed dose of 74.4 Gy. The Y-90 was infused into to the left lobe on 3/9/2011 at approximately 10 (EST). Based on the Authorized User's reassessment of the left lobe volume, the dose to the left lobe is calculated, post-administration, to be 159.4 Gy. The patient was notified of the event on 3/9/2011. The referring physician was also notified on the morning of 3/10/2011. The Authorized User physician has concluded that the elevated radiation dose to the patient's liver will not result in permanent medical damage or loss of function. Upon initial investigation this event appears to possibly be due to a problem in transcription however causes and corrective actions are still being evaluated. 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.
ENS 4543614 October 2009 21:00:0010 CFR 35.3045(a)(1)Patient Received Approximately 76% of the Prescribed DoseA three year old boy was undergoing a palliative treatment for a cancer related illness with I-131. The boy was prescribed 180.5 milliCuries of I-131 by his physician. During the treatment, a technician noticed that there were air bubbles in the intravenous tubing leading to the boy and stopped the treatment. Upon subsequent investigation, it was revealed that the patient only received 138 milliCuries of the prescribed 180.5 milliCuries of I-131, which is approximately 76% of the prescribed dose. The patient's physician has been notified, and is making a decision whether to inform the boy's parents. The licensee is investigating the cause of the incident. 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.