Event Notification Report for April 24, 2014

NON-LICENSED CONTRACT SUPERVISOR CONFIRMED POSITIVE ON FOLLOW-UP FITNESS FOR DUTY TEST

A non-licensed contract supervisor was confirmed positive for alcohol on a follow-up fitness for duty test. The supervisor's access to the facility has been terminated. The licensee has notified the NRC Resident Inspector.

LOSS OF SECONDARY CONTAINMENT DURING ROUTINE SWAP OF A POWER SUPPLIES

"On April 24, 2014 at 0230 [EDT], Secondary Containment Zone 3 (Unit 1&2 Reactor Building) differential pressure lowered to 0.10 [negative inches] WG [Water Gauge] when restoring Unit 1 Zone 3 HVAC during a routine swap of RPS power supplies, due to a trip of the Unit 1 Zone 3 Supply fan. Zone 3 differential pressure was restored to > 0.25 [negative inches] WG at 0243 hours. Zone I (Unit 1 Reactor Building) ventilation is isolated with secondary containment relaxed for refuel outage on Unit 1. Zone II (Unit 2 Reactor Building) ventilation remained in service and stable.

"Zone 3 differential pressure recovered to SR 3.6.4.1.1 requirements of 0.25 WG [negative inches] at 0243 hours and was verified to be stable. LCO 3.6.4.1 was entered at 0230 hours and exited at 0313 hours. Tech Spec Secondary Containment Operability requires a negative pressure of at least 0.25 [negative inches] WG for all three Reactor Building Ventilation Zones when secondary containment is required.

"This event is being reported under 10CFR50.72(b)(3)(v)(C) and per the guidance of NUREG-1022,Rev 3 section 3.2.7 as a loss of a Safety Function. There is no redundant Susquehanna Secondary Containment System."

The licensee notified the NRC Resident Inspector.

AGREEMENT STATE REPORT - FAILURE OF SOURCE TO RETRACT

The following information was received via E-mail:

"On the evening of April 24, 2014 Elekta, (Georgia license - GA 1153-2) working under a Nebraska reciprocity general license, was installing the initial source (9.98 curies of lr-192) into the new Flexitron unit at Saint Francis Medical Center (Nebraska Radioactive Material License # 08-09-01) in Grand Island, Nebraska. During the upload procedure, the source did not completely retract into the safe and became hung-up on the in-drive. The device gave an error stating the source was detached from the cable. Following the manufacturer's recommended emergency procedures, the engineer entered the room to investigate the issue and determined the source cable needed to be cut to remove it from the stuck source drive. The Field Service Engineer (FSE) then quickly cut the exposed source cable and, using pliers, manually inserted the source into the transport container. However, due to the fact that the source cable was short, he could not get it completely into the center of the shielded transport container. The exposure rate at one meter from the transport container was 200 mR/hour. The facility physicist and FSE insured the door to the treatment room was sealed and marked so no one could enter overnight.

"The following morning, April 25, 2014, work began to construct temporary shielding made of lead bricks on a trolley in order to transport the container to the facility hot lab. Additionally, arrangements were made with Elekta's source manufacturer to acquire a type A container of the proper size to house and ship the source transport container to their facility, thus removing it from St. Francis premises.

"Elekta's Radiation Safety Officer failed to notify the State of Nebraska Radioactive Material's Program in a timely manner. The incident occurred after business hours and Friday April 25, 2014 was a State holiday (Arbor Day). No call was made to the emergency call number for the State and the information was only obtained by the Nebraska Program Manager by a series of e-mails and a voicemail after 0800 CDT on Monday, April 28, 2014."

Item Number: NE14003

* * * UPDATE FROM TRUDY HILL TO CHARLES TEAL AT 1659 EDT ON 6/16/14 * * *

The following information was received via email:

"On April 29, 2014, a special Type A container from Alpha Omega Services (AOS) arrived on site and the source was packaged in it for shipment. On May 1, 2014, source was shipped to AOS. On May 7, 2014, the source was received at AOS facility for safe decay storage before shipping back to Mallinckrodt.

"On May 21 & 22, 2014, the HDR unit involved in the incident was shipped back to Nucleotron B. V. in the Netherlands for investigations. No results as of June 16, 2014."

Notified R4DO (Hay), R1DO (Welling) and FSME Event Resource via email.

* * * UPDATE FROM TRUDY HILL (VIA EMAIL) TO HOWIE CROUCH AT 1123 EDT ON 09/09/14 * * *

The following information was obtained via email:

"As of July 25, 2014 there is still no determination as to the cause of the source hang-up. The HDR unit is still being analyzed at the factory in the Netherlands.

"As of August 27, 2014, Elekta's R & D Department has not uncovered the root cause of the incident. Extensive analysis of the drive and the log files have not been able to reproduce the specific error. R & D are in the final stages of the root cause investigation and should be completed soon.

"On September 8, 2014, Elekta submitted their close out report on the incident. After exhaustive & extensive analysis of the drive and the log files, the R & D Department has not been able to reproduce the specific error and could not uncover the root cause of the incident."

Nebraska considers this report as closed.

Notified R1DO (Jackson), R4DO (Azua) and FSME Events Resource via email.

AGREEMENT STATE REPORT - SECOND SCHEDULED MEDICAL DOSE NOT DELIVERED DUE TO EQUIPMENT FAILURE

The following information was provided by the State of Virginia via facsimile:

"On April 24, 2014, the licensee performed a two part therapy procedure using yttrium-90 microspheres (Sirtex SirSpheres). The procedure was to treat the same lobe of the liver via two different arterial pathways. There were no problems with the first injection, but the second injection failed and none of the yttrium-90 was delivered to the patient. The licensee determined that the failure occurred because of a faulty Surefire Medical catheter. The authorized user decided not to repeat the administration of the second dose but will treat the region with an alternate method. The licensee indicated that the prescribed dosage for the first injection was 11.7 millicuries and that 12.7 millicuries (27,500 rem to the target region of the loft lobe) was delivered. The prescribed dosage for the second injection was 8.3 millicuries (to give a dose of 26,200 rem to the targeted region) but no activity was delivered. This resulted in a medical event for the second injection (or fraction) as well as for the entire procedure."

VA Event Report ID No.: VA-2014-003

* * * UPDATE ON 5/9/14 AT 1420 EDT FROM CHARLES COLEMAN TO DONG PARK * * *

The following information was provided by the Commonwealth of Virginia via facsimile:

"The licensee submitted a written report on May 9, 2014, which contained additional information from its review of the event. The licensee's review concluded that the failure of the catheter (Surefire Medical, Model SHF-38120-mT) during the second procedure was attributable a kink or fold in a basket on the catheter which resulted in a catheter occlusion. The licensee concluded that the short arterial segment used for the arterial pathway and the acute angle at the arterial origin, along with possible manipulation or patient movement, resulted in a kink or fold as the basket entered the acute angle of the artery. The catheter will be returned after decay of the radioactivity to the manufacturer for examination. The licensee submitted corrective actions for the procedure which include retraining of personnel to use extra care in ensuring the catheter is firmly set and to flush the catheter prior to administration of the microspheres to ensure there is no occlusion. The agency will review implementation of the corrective actions
during a future inspection."

Notified R1DO (Lilliendahl) and FSME Events Resource via email.

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.