Event Notification Report for August 04, 2017

AGREEMENT STATE REPORT - Y-90 TREATMENT UNDERDOSE

The following information was provided by the State of California via email:

"The RSO [Radiation Safety Officer] of Loma Linda Medical Center notified the RHB [Radiologic Health Branch] Brea ICE [Inspection, Compliance and Enforcement] office on August 7, 2017, that a medical event occurred on Friday, August 4, 2017. A patient was admitted to the hospital for treatment of liver carcinoma. The treatment plan involved use of Nordion model TheraSpheres (Y-90 glass microspheres manual brachytherapy) for radio-embolism to the right lobe of the liver. The patient's written directive called for aggregate treatment of 121Gy (5.241 GBq) of Y-90 to the right lobe target area, but only 9.7 Gy (0.420 GBq) was delivered. The overall percent delivery to target tissue was 8.1%.

"The patient's lung dose from shunting was 1.01 Gy at 4.8% lung shunting factor. The patient and referring physician were informed of the event on 8/4/2017. The medical event is still being investigated, but is thought that a slow injection flowrate may have caused sedimentation of the microspheres in the delivery system. After a few days for decay, a more intensive review of the delivery system will be conducted."

CA 5010 Number: 080417

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.

AGREEMENT STATE REPORT - UNDERDOSE TO PATIENT

The following information was received via E-mail:

"The licensee's RSO reported an event that resulted in an underdose to the patient. At 1215 CDT on August 4, 2017, licensee staff were administering a 40.4 mCi dose of Y-90 microspheres to the patient. The preliminary finding is that the patient took a deep inspiration which moved the base catheter and possibly changed its position or created a kink in the catheter. The first 3-4 aliquots were delivered before the plunger met resistance and the procedure aborted. The licensee estimates that 21.5 mCi was delivered (underdose 46.9%). They estimate that the patient received 50+ Gy to the intended area and there were no microspheres to an unintended target. Written report forthcoming."

Illinois Item Number: IL177016

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.

SECONDARY CONTAINMENT INOPERABLE DUE TO OPENING IN SERVICE WATER PIPING

"On August 4, 2017, at 1511 EDT, Unit 1 Secondary Containment was declared inoperable due to a small (i.e., approximately 0.75 inch diameter) hole in Service Water system piping which was found during ultrasonic testing activities. The affected portion of piping penetrates Secondary Containment and flow in the piping creates a vacuum condition; thus bypassing Secondary Containment. The identified hole is being evaluated with respect to its impact on operability of the Service Water system.

"This condition is being reported in accordance with 10 CFR 50.72(b)(3)(v)(C), as an event or condition that could have prevented fulfillment of a safety function needed to control the release of radioactive material.

"This event did not result in any adverse impact to the health and safety of the public.

"Initial Safety Significance Evaluation: The initial safety significance of this event is minimal. At the time of discovery, Unit 1 was at 100% steady state conditions. Reactor Building Ventilation was in service in a normal alignment. No abnormal radioactivity conditions existed within Secondary Containment.

"Corrective Actions: Temporary repair of the affected Unit 1 Service Water piping has been completed. This repair was evaluated by Engineering and it has been determined that the repair meets the requirements to maintain Secondary Containment operable. Unit 1 Secondary Containment operability was restored at 1704 EDT on August 4, 2017."

The licensee notified the NRC Resident Inspector.

* * * RETRACTION FROM MIKE BRADEN TO RICHARD SMITH AT 1447 EDT ON 9/27/17 * * *

"Based upon further evaluation, Duke Energy is retracting Event Notification 52888. The safety objective of Secondary Containment is to limit the release of radioactivity to the environment after an accident so that the resulting exposures are kept to a practical minimum and are within regulatory limits. A bounding engineering evaluation was performed which demonstrates that potential releases from Secondary Containment could not have resulted in offsite or control room doses exceeding regulatory limits. Furthermore, the condition did not impact Technical Specification operability of Secondary Containment in that the ability of Secondary Containment to maintain the required vacuum was not impacted. Therefore, this condition does not represent an event or condition that could have prevented fulfillment of a safety function needed to control the release of radioactive material and is not reportable in accordance with 10 CFR 50.72(b)(3)(v)(C), and the event notification is being retracted."

The NRC Senior Resident was notified of this retraction.

Notified R2DO (A. Masters).