[129151895]
On (b)(6) bodily fluids were observed inside the source guide tubes following a treatment using the miami applicator. The source guide tubes, length gauge, and marker wire that were used that day were removed from clinical use and varian was notified. The hdr system was not used again until the system was rebuilt by varian service engineers and a new ir - 192 source was installed. Varian was consulted regarding the miami applicator. The miami applicator was leak-tested sing a vase of water and the leak problem was found to be reproducible. By using three judiciously placed o-rings, the leaking was stopped. It was decided that we would try to purchase a newer version of the miami applicator set as soon as possible. In the interim, we would use o-rings which would be discarded after each use. The source guide tubes that had been contaminated and removed from clinical use were disposed of, as per varian recommendation. On (b)(6), bodily fluids were again observed inside the source guide tubes following a treatment using the miami applicator, despite the use of protective o-rings. Varian was again notified, and the involved source guide tubes were disposed of. The miami applicator has been permanently removed from clinically use. The afterloader was once again rebuilt and a new source was installed. Through the investigation of the 2 events, it was revealed that our center is not the only clinic that has seen its hdr unit contaminated due to design flaw of the miami applicator. Furthermore, the effect of the contamination of the transfer tube is very subtle and can be hard to notice and might go undetected and some centers might not realize that their hdr unit has been contaminated and therefore increase the potential risk of failure of the drive system that could lead to the source not retracting properly or completely. Varian was contacted and device was leak-tested and the problem found to be reproducible. After first event we felt the solution would prevent a second occurrence. The second occurrence was a different device failure mode. The main o-ring seemed to have failed. For each instances, the treatment constituted of 3 fractions. In the (b)(6) event, the device malfunctioned after the second fracture and we had to change device (split ring and tandem) to complete the 3rd fraction. For the (b)(6) event, the device failed during / after the 3rd fraction and treatment was successfully completed. In all cases, there were no adverse impact on the pt. No medical issues.
Patient Sequence No: 1, Text Type: D, B5