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Event Notification Report for June 22, 2017

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
06/21/2017 - 06/22/2017

** EVENT NUMBERS **


52721 52804 52817

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Agreement State Event Number: 52721
Rep Org: ARKANSAS DEPARTMENT OF HEALTH
Licensee: BAXTER HEALTHCARE CORPORATION
Region: 4
City: MOUNTAIN HOME State: AR
County:
License #: GL-0026
Agreement: Y
Docket:
NRC Notified By: ANGIE D. HALL
HQ OPS Officer: DONG HWA PARK
Notification Date: 05/02/2017
Notification Time: 14:16 [ET]
Event Date: 04/29/2017
Event Time: 18:30 [CDT]
Last Update Date: 06/21/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
MARK HAIRE (R4DO)
NMSS_EVENTS_NOTIFIC (EMAI)

Event Text

AGREEMENT STATE REPORT - FIXED GAUGE WITH STUCK SHUTTER

The following report was received from the State of Arkansas via e-mail:

"The Arkansas Department of Health was notified via telephone and e-mail on Monday, May 1, 2017, at approximately 1337 [CDT] of the licensee's general licensed device stuck shutter and the failure of the shutter mechanism. The equipment failure appears to have occurred from strong thunderstorms. The lockout procedure was verbally verified with the licensee.

"The licensee's fixed gauge is a ThermoFisher Scientific, Model Number E-SFL10-XX, Serial Number SP9810, which contains approximately 1,178.42 mCi Kr-85 (approximately 43.60 GBq Kr-85).

"The original activity: 1,250 mCi Kr-85 (approximately 46.25 GBq Kr-85) as of June 1, 2016. The source's Model Number is TFC-185 and the Serial Number is QC00256.

"Licensee operations with the gauge are twenty-four hours a day. The gauge has a fail-safe closing shutter mechanism and the gauge immediately went into the safe mode electronically during the thunderstorm. The closed shutter position was verified by the visual colored indicators in place.

"There have been no known radiation exposures to personnel and/or members of the public. There have been no known radiological health and safety concerns.

"The shutter will be repaired by the manufacturer today, May 2, 2017, whom will perform a root cause analysis. The State of Arkansas is awaiting information from today's evaluation, repairs, and surveys.

"The State is awaiting a 30 day written report from the licensee."

State Event Number: ARK-2017-002

* * * UPDATE ON 6/9/17 AT 1507 EDT FROM ANGIE HALL TO BETHANY CECERE * * *

The following follow-up report was received from the State of Arkansas via e-mail:

"The [Arkansas] Department [of Health] has received the required thirty (30) day report from the licensee, along with the related exposure survey and service reports from the manufacturer.

"The licensee states, 'We have several of these gauges that have been operating normally for several years. Due to the nature of this repair and the fact that this is the only time we have ever had to do this repair, it is my belief that a component in the device failed to operate as intended. The technician scraped paint off the surface of the shutter/flag mechanism that would help the mechanism stick to the magnet. The technician also tightened and applied thread lock to the securing hardware for the magnet. Both items should have been done at the factory.'

"The manufacturer's Field Engineer (also known as Technician) stated, 'I believe the issue started with the holding magnet being loose. This may have caused the solenoid to work harder and fail, and that could have caused the board to fail.'

"The manufacturer's Radiation Safety Officer stated, 'Thermo EGS Gauging LLC. is aware of the shutter mechanism failing in the closed or failing to the closed position on the TFC-185 and the TFC-190 sensors. The R&D manufacturing team has been working on a engineering project to correct this issue. We are currently in the testing phase and will manufacture all future sensors with the updated materials and parts. There is also an upgrade retrofit kit in the works for existing sensors that are demonstrating/developing this shutter issue. Currently we are sending out Field Service engineers to the customer's site to offer temporary repairs on an as needed basis.'

"The Department is waiting on a response from the manufacturer concerning the above statement.

"There have been no known radiological health issues, radiological exposures, safety hazards, or concerns to personnel or members of the public during this event.

"Event Cause: Equipment failure/design, manufacturing, or installation error.

"Corrective Action by licensee: New equipment obtained and repairs made with engineering change to system.

"Reporting Requirement Information:

"Arkansas State Board of Health 'Rules and Regulations for Control of Sources of Ionizing Radiation' RH-1502.f.2 and RH-402.c.

"U.S. Nuclear Regulatory Commission (NRC) Regulations Title 10 CFR Section 30.50 (b) (2) - Equipment is disabled or fails to function as designed, and Title 10 CFR Section 21.21 - A failure to comply or a defect affecting a basic component that is supplied for a facility or an activity that is subject to licensing requirements.

"The licensee and manufacturer reports and surveys have been sent to Randy Erickson, Regional State Agreement Officer, U.S. NRC, Region IV Office, and the NRC Headquarters Operations Center.

"Note: Leak tests are not required for this type of gauge."

NMED Item Number 170231.

Notified R4DO (Rollins) and NMSS Events Notification by email.

* * * UPDATE ON 6/21/17 AT 1407 EDT FROM ANGIE HALL TO BETHANY CECERE * * *

The following follow-up report was received from the State of Arkansas via e-mail:

"The Department has received clarification from the manufacturer's Radiation Safety Officer, stating in part, 'Due to a manufacturing defect of some source housing parts, about 10% of our sensors sold in the past could be affect' (affected).

"He also stated, 'Our customer Baxter Healthcare is aware of this issue and unfortunately cannot provide a solution to them until their sensors develop this issue on a case by case basis.'

"The Department considers this event to be closed."

Notified R4DO (Gaddy) and NMSS Events Notification by email.

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Agreement State Event Number: 52804
Rep Org: LOUISIANA RADIATION PROTECTION DIV
Licensee: ALPHA-OMEGA SERVICES, INC.
Region: 4
City: VINTON State: LA
County:
License #: LA-10025-L01
Agreement: Y
Docket:
NRC Notified By: JOE NOBLE
HQ OPS Officer: DONG HWA PARK
Notification Date: 06/14/2017
Notification Time: 16:29 [ET]
Event Date: 06/13/2017
Event Time: 07:30 [CDT]
Last Update Date: 06/14/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
VIVIAN CAMPBELL (R4DO)
NMSS_EVENTS_NOTIFICA (EMAI)

Event Text

AGREEMENT STATE REPORT - INCORRECT SOURCE SHIPMENT

The following report was received from the Louisiana Department of Environmental Quality [LDEQ] via email:

"Event Date and Time: On June 13, 2017, 0730 [CDT] the e-mail was received by LDEQ. The report was for two Elekta Clients under timely renewals who both received Ir-192 sources for HDR [High Dose Rate] units. Neither set of documentation matched the sources it was accompanying. Both sources were manufactured, calibrated and shipped from the A&O [Alpha-Omega Services, Inc.], LA facility on April, 27, 2017.

"Facility #1: A report of an HDR source being shipped to Texas Oncology PA where the source activity was less than the activity ordered and documented from the source received. The source received was actually 8.98 Ci Ir-192, but the shipping documents and source information listed the source as 11.28 Ci Ir-192. The mis-documented source was returned and a new source with the correct activity and documentation was requested. The source was an exchange source as a replacement source for the Texas Oncology PA, dba Texas Cancer Center Sherman [TCCS], Sherman, TX 75090. TX License # L05019, Amendment #23, Expiration date: January 31, 2016. The licensee is under a timely renewal and on Amendment #31. The Source S/N D36G1424.

"Facility #2: The report of an HDR source being shipped to New York Oncology Hematology PC (NYOH), Albany, New York, 12206. NYSDH Radioactive Material License No. 5284, Amendment #6, DH Number 09-1113. The HDR source received was 13.88 Ci of Ir-192 on May 10, 2017. The documentation for the source received was 11.01 Ci of Ir-192. This source is being held for decay and will be put into service June 13, 2017. A&O sent a source with incorrect documentation that is in violation NYOH license for activity received and activity installed in the HDR unit. The Source S/N D36G1425.

"A&O is a source supplier for Elekta HDR units. Elekta's ordering process notifies A&O when sources should be shipped/supplied their licensees.

"Event Location: The shipments originated from Alpha and Omega Services, Vinton, LA 70668 and were delivered to TCCS, Sherman, TX 75090 and NYOH, Albany, New York 12206. Neither facility received the quantity of radioactive material they ordered and were licensed to receive nor was the documentation for the radioactive material correct. The facilities were licensed each to receive an Ir-192 HDR source.

"Event type: Calibrating, shipping and delivery of radioactive material in quantities greater than the licensed activities and under documented quantities. The licenses were correct, but the sources shipped were greater than the facility was licensed to receive and/or the documentation accompanying the RAM Ir-192 sources for each HDR units was incorrect. A&O explained that their reference numbers were mixed up during the manufacturing process.

"The A&O errors were detected by TCCS and NYOH licensees when they were performing their QC/QA on the active sources prior to patient treatment.

"The shipments were intact and not damaged. The sources were secure and in the hands of trained radiation safety personnel. Health and safety to the radiation workers and general public was not the issue. The issue was the reference numbers did not match the calibration activities of each source and wrong activities were shipped.

"Notification: On June 8, 2017, the error, quantities of RAM greater than licensed activity was discovered and reported to A&O. On June 8, 2017, the replacement source was shipped to TCCS. The incident preliminary notification was reported to the LDEQ, Assessment Radiation Section by e-mail on June 13, 2017. Reported to the NRC as LAC 33:XV.340.C. For not reviewing a radioactive material license before transferring radioactive material and LAC 33:XV.328.L.1.C. A permanent label was not affixed to the source or device containing the information on the radionuclide."

LA Event Report ID No.: LA-170009

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Power Reactor Event Number: 52817
Facility: COMANCHE PEAK
Region: 4 State: TX
Unit: [1] [2] [ ]
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: ROBERT DANIELS
HQ OPS Officer: DONALD NORWOOD
Notification Date: 06/21/2017
Notification Time: 16:25 [ET]
Event Date: 06/21/2017
Event Time: 10:00 [CDT]
Last Update Date: 06/21/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(ii)(B) - UNANALYZED CONDITION
Person (Organization):
VINCENT GADDY (R4DO)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
1 N Y 100 Power Operation 100 Power Operation
2 N N 0 Cold Shutdown 0 Cold Shutdown

Event Text

POSTULATED FIRE EVENT COULD ADVERSELY IMPACT SAFE SHUTDOWN EQUIPMENT

"During the review of an electrical circuit coordination calculation to support an ongoing revision of the Fire Safe Shutdown Analysis (FSSA), a lack of appropriate circuit protection coordination was identified in the coordination of electrical protective devices on 118 VAC electrical panels operating in bypass mode of operation.

"One or more of these electrical panels could be lost for various 10 CFR Appendix R III.G.2 fires outside the Control Room at CPNPP [Comanche Peak Nuclear Power Plant] due to circuit coordination issues. This could adversely affect safe shutdown equipment and potentially cause the loss of the ability to conduct a safe shutdown as required by 10 CFR 50 Appendix R.

"Immediate compensatory actions are being taken to establish (or confirm already existing) fire watches in the Fire Areas containing the associate circuits which can potentially jeopardize the FSSA.

"This condition is reportable in accordance with 10 CFR 50.72(b)(3)(ii)(B) as an unanalyzed condition.

"The NRC Resident Inspector has been notified."

Page Last Reviewed/Updated Thursday, June 22, 2017
Thursday, June 22, 2017