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Event Notification Report for March 14, 2016

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
03/11/2016 - 03/14/2016

** EVENT NUMBERS **


51643 51759 51766 51767 51768

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Part 21 Event Number: 51643
Rep Org: FISHER CONTROLS INTERNATIONAL
Licensee: FISHER CONTROLS INTERNATIONAL
Region: 3
City: MARSHALLTOWN State: IA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: GEORGE BAITINGER
HQ OPS Officer: JEFF ROTTON
Notification Date: 01/08/2016
Notification Time: 16:25 [ET]
Event Date: 11/11/2015
Event Time: [CST]
Last Update Date: 03/11/2016
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21(a)(2) - INTERIM EVAL OF DEVIATION
Person (Organization):
ANTHONY DIMITRIADIS (R1DO)
ANTHONY MASTERS (R2DO)
KARLA STOEDTER (R3DO)
VIVIAN CAMPBELL (R4DO)
PART 21/50.55 REACTO (EMAI)

Event Text

PART 21 - COMMERCIAL GRADE CAP SCREWS PROVIDED WITH SAFETY RELATED FISHER TYPE 3570 POSITIONERS

The following information was provided by the reporting organization via fax:

"Pursuant to 10 CFR 21.21(a)(2), Fisher Controls International LLC ('Fisher') is providing required written interim notification of a failure to comply concerning Type 3570 positioners when provided as safety-related equipment.

"On November 11, 2015, Fisher became aware of an issue with the dedication of a Type 3570 positioner. When replacement Type 3570 positioners are ordered, the two cap screws (SAE J429 Grade 5 cap screws/size 3/8-16x1.5) used for mounting the positioner to the actuator cylinder are also included. It was not clearly communicated to the end user that these mounting cap screws are included with the positioner. Further, the dedication plan only addresses the 3570 positioner and does not include dedication of the mounting cap screws.

"As a result, these cap screws had not been dedicated on any safety-related Type 3570 positioner orders. There is no reason to believe any of the cap screws supplied were defective, only that they were not dedicated and were therefore supplied as commercial grade items. There have been no reported failures of the cap screws in question.

"An extent-of-condition investigation is underway to identify all potentially affected bolt-on accessories. Any identified affected products will be reported per the requirements of 10 CFR 21.21 (b). This extent-of-condition review is expected to be completed by January 29, 2016.

"Corrective Action 1791 has been opened to document corrective actions taken to prevent reoccurrence.

"Should there be any further questions concerning this matter, please contact Benjamin Ahrens, Manager, Quality by email at Benjamin.Ahrens@Emerson.com or via phone at 641-754-2249.

Individual informing the NRC: Chad Engle, Director, Nuclear Business Unit, Fisher Controls International LLC, phone (641) 754-3011.

* * * UPDATE FROM GEORGE BAITINGER TO HOWIE CROUCH VIA FAX AT 1528 EST ON 2/2/16 * * *

The following information is summarized from a fax received from Emerson Process Management (Fisher Controls):

On January 22, 2016, Fisher Controls completed their extent-of-condition investigation and determined that seven of their thirty two product series have the potential to include non-dedicated cap screws and mounting studs.

The vendor plans to complete their final report within 45 days.

Notified R1DO (Rogge), R2DO (Musser), R3DO (Kozak), R4DO (Pick) and the Part 21 group via email.

* * * UPDATE FROM LYNN SANDERS TO DONG PARK VIA EMAIL AT 1749 EST ON 3/11/16 * * *

The following information is summarized from an email received from Emerson Process Management (Fisher Controls):

"The supplied instrument assemblies in question were subjected to the processing requirements of Fisher Controls FMP2K27 (Control of Commercial Grade Items to be Dedicated for Use in Nuclear Safety-Related Applications) and were supplied as safety-related components. However, Fisher supplied various mounting parts (in addition to the requested product) that were not processed under FMP2K27; thus, such parts were supplied as commercial items.

"This issue was first discovered in relation to the cap screws used for mounting a 3570 positioner (please see Interim Report dated 01/08/2016). Fisher conducted an extent-of-condition investigation to include all safety-related actuator-mounted accessories. In total, thirty -two (32) actuator-mounted item types were investigated. It is Fisher's opinion the failures to dedicate these mounting accessories do not pose an inherent safety risk.

"Additionally, there are no known field issues with respect to the affected equipment and all such non-dedicated equipment passed the required standard testing.

"Each affected customer needs to: (i) evaluate the application of each referenced item number for all respective orders; (ii) determine whether the incorrectly processed mounting parts are in violation of regulatory requirements; (iii) contact Fisher or otherwise arrange for the procurement of properly processed mounting parts for use in those applications found to be in violation. In addition, a Corrective Action Request (CAR 1791) has been initiated by Fisher to prevent reoccurrence of this issue."

Notified R1DO (Dimitriadis), R2DO (Suggs), R3DO (Riemer), R4DO (Proulx), and the Part 21 group via email.

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Non-Agreement State Event Number: 51759
Rep Org: SAINT ALPHONSUS HEALTH SYSTEM
Licensee: SAINT ALPHONSUS HEALTH SYSTEM
Region: 4
City: BOISE State: ID
County:
License #: 11-27396-01
Agreement: N
Docket:
NRC Notified By: ERIC COLAIANNI
HQ OPS Officer: JOHN SHOEMAKER
Notification Date: 02/26/2016
Notification Time: 18:36 [ET]
Event Date: 02/26/2016
Event Time: 11:20 [MST]
Last Update Date: 03/11/2016
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
JACK WHITTEN (R4DO)
NMSS_EVENTS_NOTIFIC (EMAI)

Event Text

MEDICAL EVENT - UNDERDOSE TO PATIENT

Notification from the licensee's Radiation Safety Officer, of a medical event that occurred on February 26, 2016 at 1120 MST, in which the Y-90 SIR-Sphere dose delivered to the patient's liver was less than the prescribed dose. The intended dose to the patient was 86 mCi, however, most of the dose remained in the catheter and it is estimated the patient received 13 mCi. The patient and attending physician have been informed and there was no harm to the patient.

* * * UPDATE ON 3/11/16 AT 1459 EDT FROM ERIC COLAIANNI TO DONG PARK * * *

The following was received via email:

"Per NRC requirement noted in 10 CFR Subpart M, Section 30.3045 (a)(1) and 30.3045(d), this report is being submitted to provide details of a medical event that occurred on February 26, 2016. This event was previously reported by phone as required in 10 CFR, Subpart M, Section 30.345(c) on February 26, 2016 at 1836 EST to NRC Operations Center.

"Patient was to receive 3.1 GBq of Y90 Theraspheres for treatment of right liver lobe hepatocellular carcinoma. Assay dose of 3.2 GBq was prepared via manufacture protocol and brought to the Interventional Radiology Suite and placed into the delivery apparatus. Manufacturer representative was on-site and provided further instruction on apparatus setup of infusion lines. Surefire catheter was deployed in the same location of the initial pre-treatment planning procedure. After angiography confirmed this position, the Theraspheres product was delivered and the entire delivery apparatus was removed from the patient and placed in the appropriate waste jar. After the infusion, and per protocol, post implantation measurements were taken both of the patient and infusion set. It was discovered that the patient's readings were significantly lower than expected along with higher readings than expected within the infusion line. Per protocol the patient was imaged post Y90 implantation which demonstrated activity noted in the target location. The radiologist's interpretation of that exam notes activity within target area with no activity seen in the chest or abdomen, outside the intended target area. Review of final calculations indicates that the patient received .491 GBq which was approximately 15% of the written directive. Imaging of the infusion lines within the waste jar demonstrate activity of the Y90 Theraspheres retained within the infusion lines.

"After review with the Surefire catheter representative, it appears the Surefire apparatus may not have been fully extended which would have potentially provided an occlusion and prevented all of the Theraspheres from passing through the device. [The licensee is] continuing to investigate the cause.

"The patient was contacted 3 days post procedure to follow up to determine any symptomatic episodes. The patient stated that the patient has not felt any effects from the procedure. The patient was also seen two weeks post procedure for review of any symptoms from the procedure. The patient to date has not reported any unusual symptoms.

"[The licensee] ordered a different, and newer, Surefire product to use instead of the Surefire product that has been used for previous Y90 cases. [The licensee] discontinued the use of the Surefire product at issue for this procedure.

"The patient was notified immediately post procedure that it appeared that the patient received less than the total intended dosage of the Y90 Theraspheres. The patient has been followed within clinic as set forth above. The patient will continue to be followed as medically appropriate."

Notified R4DO (Proulx) and NMSS 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.

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Non-Agreement State Event Number: 51766
Rep Org: EUROFINS EATON ANALYTICS, INC.
Licensee: EUROFINS EATON ANALYTICS, INC.
Region: 3
City: SOUTH BEND State: IN
County:
License #: 13-32402-01
Agreement: N
Docket:
NRC Notified By: DALE PIECHOCKI
HQ OPS Officer: HOWIE CROUCH
Notification Date: 03/03/2016
Notification Time: 14:39 [ET]
Event Date: 03/03/2016
Event Time: 14:38 [EST]
Last Update Date: 03/03/2016
Emergency Class: NON EMERGENCY
10 CFR Section:
20.2201(a)(1)(ii) - LOST/STOLEN LNM>10X
Person (Organization):
NICK VALOS (R3DO)
NMSS_EVENTS_NOTIFIC (EMAI)

This material event contains a "Less than Cat 3 " level of radioactive material.

Event Text

LOST ELECTRON CAPTURE DETECTOR SOURCES

"Eurofins Eaton Analytical, Inc., (EEA) is reporting two lost ECDs [Electron Capture Detector] serial# B794 and A10856 that were listed under the General License GL-65970 held by Underwriters Laboratories, Inc.

"A notice to the NRC was sent on November 25, 2015 stating that the devices under General License GL-65970 were transferred to EEA. On February 4, 2016 it was brought to our attention by NRC Region III's Material Safety Licensing Branch, that ECDs, Serial# B794 and A10856 should be in our possession. After a thorough search of the facility and records we could not locate these ECDs.

"(i) Lost device ECD, Serial# B794, Model# 03-917440-00, isotope Ni-63, activity 15 mCi, was manufactured by Varian Associates, Inc.
(ii) Lost device ECD, Serial# A10856, Model# 02-0001972-00, isotope Ni-63, activity 15 mCi, was manufactured by Varian Associates, Inc.
(iii) Both ECDs were not located in a recent inventory check.
(iv) Both ECDs were more than likely returned to Varian for disposal before 2008.
(v) No known exposures have been reported from this ECD at this time.
(vi) [EEA] performed a thorough search of the facility and in-house records. In addition, [EEA] attempted to contact Varian. In 2010 Varian was sold off to Agilent and Buker Corp. Buker Corp then sold off their portion of Varian Gas Chromatography equipment to Scion in 2014. All three companies were contacted in order to determine who currently holds the Varian ECD records. None of the companies contacted claimed to hold the records.
(vii) [EEA] now maintains a list of ECDs showing each ECD location. The list is maintained by the laboratory and monitored by the RSO."

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

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Fuel Cycle Facility Event Number: 51767
Facility: NUCLEAR FUEL SERVICES INC.
RX Type: URANIUM FUEL FABRICATION
Comments: HEU CONVERSION & SCRAP RECOVERY
                   NAVAL REACTOR FUEL CYCLE
                   LEU SCRAP RECOVERY
Region: 2
City: ERWIN State: TN
County: UNICOI
License #: SNM-124
Agreement: Y
Docket: 07000143
NRC Notified By: MICHAEL C. TESTER
HQ OPS Officer: STEVE SANDIN
Notification Date: 03/04/2016
Notification Time: 10:26 [ET]
Event Date: 03/03/2016
Event Time: 21:23 [EST]
Last Update Date: 03/04/2016
Emergency Class: NON EMERGENCY
10 CFR Section:
20.1906(d)(1) - SURFACE CONTAM LEVELS > LIMITS
Person (Organization):
MARVIN SYKES (R2DO)
NMSS_EVENTS_NOTIFIC (EMAI)

Event Text

CONTAMINATED RADIOACTIVE MATERIAL SHIPMENT

"On March 3, 2016, at approximately 1745 [EST], a radioactive material shipment was received at NFS from the Westinghouse Electric Company in Hopkins, South Carolina. Receipt contamination and radiation surveys were completed at approximately 1905. Results indicated removable surface contamination on two of the nine radioactive material packages that exceeded the criteria of the cited regulations.

"The radioactive material shipment left the Westinghouse Electric Company facility at 1300 [EST] on March 3, 2016. It was received at the NFS receiving facility at approximately 1745 on March 3, 2016. Surface contamination and radiation surveys were initiated immediately upon receipt. Removable surface contamination in excess of 10 CFR 20.1906(d) limits was verified to be present on the external surface of two of the nine shipping containers in the shipment at 1905. Contamination was controlled at the receiving facility and successfully decontaminated below criteria of 10 CFR 20.1906(d) by approximately 2030 on March 3, 2016."

This was an exclusive shipment. The alpha contamination measured 4278 dpm/100 sq. cm. and 6345 dpm/100 sq. cm., respectively. The licensee informed Westinghouse who is conducting an investigation into this incident.

The licensee notified the NRC Resident Inspector.

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Agreement State Event Number: 51768
Rep Org: LOUISIANA RADIATION PROTECTION DIV
Licensee: LA PIGMENT COMPANY, L.P.
Region: 4
City: WESTLAKE State: LA
County:
License #: LA-6491-L01
Agreement: Y
Docket:
NRC Notified By: JOSEPH NOBLE
HQ OPS Officer: HOWIE CROUCH
Notification Date: 03/04/2016
Notification Time: 13:28 [ET]
Event Date: 03/03/2016
Event Time: 13:27 [CST]
Last Update Date: 03/04/2016
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
RICK DEESE (R4DO)
NMSS_EVENTS_NOTIFIC (EMAI)

Event Text

AGREEMENT STATE REPORT - RADIOACTIVE GAUGE SHUTTER STUCK IN THE OPEN POSITION

The following information was summarized from the State of Louisiana via email:

"[On 03/03/16, the licensee] RSO e-mailed [Louisiana Department of Environmental Quality (LDEQ)] at approximately 1330 [CST] to report that a gauge installed on a process at the LA Pigment Company facility in Westlake, LA, had a shutter malfunction. The gauge is installed on a routing process for material at the facility. The gauge shutter is stuck in the open position.

"The gauge is a Berthold Technologies, Model: Berthold Systems, LB-330 utilizing a 12 mCi Cs-137 source, S/N1768-5-90, Model: Lab. Prof. Dr. Berthold Dwg. #2653.100-001.

"On 03/04/2016, a Service Engineer with Berthold Technologies evaluated the situation and stated the source holder/shield will be replaced and the same Cs-137 source will be installed in the new source holder. The cause of the operational failure appears to be corrosion, extended wear and tear and age of the device. The service holder order was placed and anticipated delivery is 4 to 6 weeks. The device will be shipped from Germany.

"There are no exposure or health and safety issues involved with this event. The gauge and rod source will remain installed on the functioning process. The areas are posted with 'Do Not Enter or Operate' since the source cannot be locked out for human entry. The resolution of the situation will be directed by the ability to be repaired or if the gauge should be uninstalled and sent for disposal.

"The corrective action: The repairs and/or corrective actions were determined on 03/04/2016 by [the Service Engineer] and will be completed when the replacement source holders arrive."

LADEQ considers this incident closed.

State Event Report ID No.: LA 160004

Page Last Reviewed/Updated Monday, March 14, 2016
Monday, March 14, 2016