In compliance with
10CFR35.3045(c), WVU [West
Virginia University] Hospitals License # 47-23066-02, Docket # 03020233 is making telephone notification declaring a medical event.
On September 5, 2017 a patient was being administered the first fraction of a planned five fraction HDR interstitial brachytherapy treatment, treating the cervix. The written directive prescribed 5, 5Gy fractions for a total dose of 25Gy. During the first fraction, 5 separate interlocks were tripped at which time the manufacturer was contacted [at] 1535 [EDT]. Based on discussions between the medical physics team and the manufacturer, the manufacturer determined the error was caused by fluid in the catheter which may have contaminated the source and the afterloader unit. The manufacturer advised to suspend treatment, and stop all use of the afterloader until it could be decontaminated and the source could be exchanged. (Scheduled for September 7, 2017).
At the time the treatment was stopped, the patient received 0.32Gy of the planned 5Gy fraction, based on a 12.1 seconds treated of a planned 576.8 second treatment fraction.
Based on 10CFR35.3045(a)(1), the fraction of the dose differed by more than 50 rem to organ or tissue, and 10CFR35.3045(a)(1)(iii) the fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more.
In compliance with 10CFR35.3045(e), the patient and referring physician have been notified.
Upon decontamination and source exchange the patient is scheduled to complete the treatment per the written directive (September 7-9, 2017).
In compliance with 10CFR35.3045(d), a written report will be submitted to the Region One Office within 15 days.
The Licensee has notified R1(Gallaghar).
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.