Event Notification Report for August 30, 2011
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
08/29/2011 - 08/30/2011
Part 21
Event Number: 47246
Rep Org: ROSEMOUNT NUCLEAR INSTRUMENTS
Licensee: ROSEMOUNT NUCLEAR INSTRUMENTS
Region: 3
City: CHANHASSEN State: MN
County:
License #:
Agreement: Y
Docket:
NRC Notified By: DUYEN PHAM
HQ OPS Officer: BILL HUFFMAN
Licensee: ROSEMOUNT NUCLEAR INSTRUMENTS
Region: 3
City: CHANHASSEN State: MN
County:
License #:
Agreement: Y
Docket:
NRC Notified By: DUYEN PHAM
HQ OPS Officer: BILL HUFFMAN
Notification Date: 09/06/2011
Notification Time: 15:59 [ET]
Event Date: 08/30/2011
Event Time: 00:00 [CDT]
Last Update Date: 09/06/2011
Notification Time: 15:59 [ET]
Event Date: 08/30/2011
Event Time: 00:00 [CDT]
Last Update Date: 09/06/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21 - UNSPECIFIED PARAGRAPH
10 CFR Section:
21.21 - UNSPECIFIED PARAGRAPH
Person (Organization):
TODD JACKSON (R1DO)
DANIEL RICH (R2DO)
JAMES DRAKE (R4DO)
CHRISTINE LIPA (R3DO)
PART 21 E-MAIL GROUP
TODD JACKSON (R1DO)
DANIEL RICH (R2DO)
JAMES DRAKE (R4DO)
CHRISTINE LIPA (R3DO)
PART 21 E-MAIL GROUP
NOTIFICATION THAT CERTAIN ROSEMOUNT PRESSURE TRANSMITTERS MAY NOT PERFORM THEIR INTENDED SAFETY FUNCTION
The following is a summary of a Part 21 notification was received from Rosemount via facsimile:
"Re: Notification under 10 CFR Part 21 on certain Rosemount Model 1153 Series B, 1154 and 1154 Series H Pressure Transmitters
"Pursuant to 10 CFR Part 21, section 21.21(b), Rosemount Nuclear Instruments, Inc. (RNII) is writing to inform [the NRC] that one (1) Model 1153 Series B, fourteen (14) Model 1154, and twenty (20) Model 1154 Series H pressure transmitters may not perform their intended safety function.
"Rosemount Nuclear Instruments, Inc. does not have complete information relating to specific plant applications and therefore cannot determine the potential effects of the condition on plant operation.
"The thirty-five (35) potentially affected Model 1153 Series B, 1154, and 1154 Series H pressure transmitters were shipped from RNII between April 19, 2011 and August 12, 2011. [The list of Plant Sites that have received the affected transmitters is provided at the end of this report.]
"If you have any questions, or require additional information related to this issue, please contact: Mike Dougherty (208) 865 -1112 or Tracy Kaluzniak (952) 949-7159.
"Identification of items supplied:
"One (1) Model 1153 Series B, fourteen (14) Model 1154, and twenty (20) Model 1154 Series H potentially affected units have been shipped.
"Identification of firm supplying the item:
"Rosemount Nuclear Instruments, Inc. 8200 Market Boulevard Chanhassen, MN 55317
"Nature of the failure and potential safety hazard:
"On each Model 1153 Series B, 1154, and 1154 Series H transmitter, four diodes are used on a circuit card assembly which is installed within the welded sensor module subassembly. These diodes convert the AC oscillator signal to a DC current proportional to the pressure applied to the sensor. The diodes (P/N DZ911218A) are manufactured by Microsemi Corporation (MSC).
"Recently an unexpected drop in yield was identified during electrical testing of the circuit card assembly. A hold was placed on production to further investigate the issue. It was determined that the drop in yield was caused by intermittent open diodes on the circuit card assembly. Failure of one diode will result in an off-scale failure of transmitter output. Failure of two or more diodes may result in an on-scale failure of transmitter output.
"MSC determined that the intermittent open electrical failures were the result of a poor solder bond formation within the diode at the cathode lead. This was caused by either inadequate heat flow or surface contamination during the component manufacturing process.
"Working with MSC, RNII used material traceability data to confirm the potential problem was limited to one manufacturer's lot code of the diode. RNII was then able to utilize material traceability data to further identify the specific shipped transmitters affected by this notification.
"On August 30, 2011, it was concluded that a substantial safety hazard may exist. Rosemount Nuclear Instruments, Inc. does not have sufficient information to determine the safety impact related to the potentially anomalous output in plant applications. As a result, a notification about the potential substantial safety hazard is being made in accordance with 10 CFR Part 21 to customers who purchased one or more of the thirty-five (35) potentially affected Model 1153 Series B, 1154, or 1154 Series H pressure transmitters.
"The corrective action which is taken, the name of the individual or organization responsible for that action, and the length of time taken to complete that action:
"(a) RNII held shipments of completed Model 1153 Series B, 1154, and 1154 Series H transmitters and determined which specific units were assembled with diodes from the suspect lot code.
"(b) RNII quarantined all Model 1153 Series B, 1154, and 1154 Series H transmitters and sub-assemblies in manufacturing while a determination was made as to which specific units were assembled with diodes from the suspect lot code.
"(c) RNII worked with the diode supplier (MSC) to determine the root cause and identify the suspect lot code. Since this part is no longer being manufactured by MSC, no corrective actions were implemented at MSC.
"(d) RNII is in the process of reworking all unshipped Model 1153 Series B, 1154, and 1154 Series H transmitters and subassemblies that were completed or in manufacturing that contained diodes from the suspect lot code.
"(e) Potentially affected pressure transmitters can be returned and reworked at the factory at the end user's request.
"(f) RNII is qualifying a substitute diode to replace the obsolete DZ911218A diode. The qualification is expected to be complete within the next six months. This qualification will be documented in an update to the Model 1153 Series B, 1154, and 1154 Series H qualification reports
"Any advice related to the potential failure of the Item:
"RNII recommends that users review the application where any of the thirty-five (35) potentially affected Model 1153 Series B, 1154 and 1154 Series H transmitters are used to determine any safety considerations in the operation of the plant. RNII recommends that potentially affected transmitters be returned to RNII for rework at the end user's earliest opportunity."
List of Affected Sites:
U.S Facilities
Calvert Cliffs -5 Transmitters
Oconee -2 Transmitters
San Onofre -1 Transmitter
River Bend -1 Transmitter
Waterford -1 Transmitter
Diablo Canyon -1 Transmitter
Farley -4 Transmitters
Foreign Facilities
Shin Kori -1 Transmitter
Ringhals -3 Transmitters
Fuqing -4 Transmitters
Fangjishan -4 Transmitters
Yangjiang -4 Transmitters
Tihange -1 Transmitter
Asco II / Vandellos II -3 Transmitters
The following is a summary of a Part 21 notification was received from Rosemount via facsimile:
"Re: Notification under 10 CFR Part 21 on certain Rosemount Model 1153 Series B, 1154 and 1154 Series H Pressure Transmitters
"Pursuant to 10 CFR Part 21, section 21.21(b), Rosemount Nuclear Instruments, Inc. (RNII) is writing to inform [the NRC] that one (1) Model 1153 Series B, fourteen (14) Model 1154, and twenty (20) Model 1154 Series H pressure transmitters may not perform their intended safety function.
"Rosemount Nuclear Instruments, Inc. does not have complete information relating to specific plant applications and therefore cannot determine the potential effects of the condition on plant operation.
"The thirty-five (35) potentially affected Model 1153 Series B, 1154, and 1154 Series H pressure transmitters were shipped from RNII between April 19, 2011 and August 12, 2011. [The list of Plant Sites that have received the affected transmitters is provided at the end of this report.]
"If you have any questions, or require additional information related to this issue, please contact: Mike Dougherty (208) 865 -1112 or Tracy Kaluzniak (952) 949-7159.
"Identification of items supplied:
"One (1) Model 1153 Series B, fourteen (14) Model 1154, and twenty (20) Model 1154 Series H potentially affected units have been shipped.
"Identification of firm supplying the item:
"Rosemount Nuclear Instruments, Inc. 8200 Market Boulevard Chanhassen, MN 55317
"Nature of the failure and potential safety hazard:
"On each Model 1153 Series B, 1154, and 1154 Series H transmitter, four diodes are used on a circuit card assembly which is installed within the welded sensor module subassembly. These diodes convert the AC oscillator signal to a DC current proportional to the pressure applied to the sensor. The diodes (P/N DZ911218A) are manufactured by Microsemi Corporation (MSC).
"Recently an unexpected drop in yield was identified during electrical testing of the circuit card assembly. A hold was placed on production to further investigate the issue. It was determined that the drop in yield was caused by intermittent open diodes on the circuit card assembly. Failure of one diode will result in an off-scale failure of transmitter output. Failure of two or more diodes may result in an on-scale failure of transmitter output.
"MSC determined that the intermittent open electrical failures were the result of a poor solder bond formation within the diode at the cathode lead. This was caused by either inadequate heat flow or surface contamination during the component manufacturing process.
"Working with MSC, RNII used material traceability data to confirm the potential problem was limited to one manufacturer's lot code of the diode. RNII was then able to utilize material traceability data to further identify the specific shipped transmitters affected by this notification.
"On August 30, 2011, it was concluded that a substantial safety hazard may exist. Rosemount Nuclear Instruments, Inc. does not have sufficient information to determine the safety impact related to the potentially anomalous output in plant applications. As a result, a notification about the potential substantial safety hazard is being made in accordance with 10 CFR Part 21 to customers who purchased one or more of the thirty-five (35) potentially affected Model 1153 Series B, 1154, or 1154 Series H pressure transmitters.
"The corrective action which is taken, the name of the individual or organization responsible for that action, and the length of time taken to complete that action:
"(a) RNII held shipments of completed Model 1153 Series B, 1154, and 1154 Series H transmitters and determined which specific units were assembled with diodes from the suspect lot code.
"(b) RNII quarantined all Model 1153 Series B, 1154, and 1154 Series H transmitters and sub-assemblies in manufacturing while a determination was made as to which specific units were assembled with diodes from the suspect lot code.
"(c) RNII worked with the diode supplier (MSC) to determine the root cause and identify the suspect lot code. Since this part is no longer being manufactured by MSC, no corrective actions were implemented at MSC.
"(d) RNII is in the process of reworking all unshipped Model 1153 Series B, 1154, and 1154 Series H transmitters and subassemblies that were completed or in manufacturing that contained diodes from the suspect lot code.
"(e) Potentially affected pressure transmitters can be returned and reworked at the factory at the end user's request.
"(f) RNII is qualifying a substitute diode to replace the obsolete DZ911218A diode. The qualification is expected to be complete within the next six months. This qualification will be documented in an update to the Model 1153 Series B, 1154, and 1154 Series H qualification reports
"Any advice related to the potential failure of the Item:
"RNII recommends that users review the application where any of the thirty-five (35) potentially affected Model 1153 Series B, 1154 and 1154 Series H transmitters are used to determine any safety considerations in the operation of the plant. RNII recommends that potentially affected transmitters be returned to RNII for rework at the end user's earliest opportunity."
List of Affected Sites:
U.S Facilities
Calvert Cliffs -5 Transmitters
Oconee -2 Transmitters
San Onofre -1 Transmitter
River Bend -1 Transmitter
Waterford -1 Transmitter
Diablo Canyon -1 Transmitter
Farley -4 Transmitters
Foreign Facilities
Shin Kori -1 Transmitter
Ringhals -3 Transmitters
Fuqing -4 Transmitters
Fangjishan -4 Transmitters
Yangjiang -4 Transmitters
Tihange -1 Transmitter
Asco II / Vandellos II -3 Transmitters
Fuel Cycle Facility
Event Number: 47225
Facility: GLOBAL NUCLEAR FUEL - AMERICAS
Region: 2 State: NC
Unit: [] [] []
RX Type: URANIUM FUEL FABRICATION
Comments: LEU CONVERSION (UF6 TO UO2)
LEU FABRICATION
LWR COMMERICAL FUEL
NRC Notified By: SCOTT MURRAY
HQ OPS Officer: MARK ABRAMOVITZ
Region: 2 State: NC
Unit: [] [] []
RX Type: URANIUM FUEL FABRICATION
Comments: LEU CONVERSION (UF6 TO UO2)
LEU FABRICATION
LWR COMMERICAL FUEL
NRC Notified By: SCOTT MURRAY
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 08/31/2011
Notification Time: 13:01 [ET]
Event Date: 08/30/2011
Event Time: 16:00 [EDT]
Last Update Date: 08/31/2011
Notification Time: 13:01 [ET]
Event Date: 08/30/2011
Event Time: 16:00 [EDT]
Last Update Date: 08/31/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
70.74 APP. A - ADDITIONAL REPORTING REQUIREMENTS
10 CFR Section:
70.74 APP. A - ADDITIONAL REPORTING REQUIREMENTS
Person (Organization):
MARVIN SYKES (R2DO)
DAVID PSTRAK (NMSS)
MARVIN SYKES (R2DO)
DAVID PSTRAK (NMSS)
COMPLETION OF ACTION PLAN (FABRICATION) MILESTONE
"In response to a Notice of Violation (NOV), Global Nuclear Fuels - America (GNFA) committed to perform a review of the existing Integrated Safety Analysis (ISA). An ISA Action Plan and schedule for performing the ISA review was described in GNF-A's response to the NOV and the second milestone (fabrication) was scheduled for completion by July 31, 2011. This milestone was subsequently extended by approximately 30 days. On 8/30/11, GNF-A completed the ISA review for the fabrication area and has identified 125 existing safety controls that are now being designated as Items Relied On For Safety (IROFS). Implementation of the revised safety basis, IROFS and application of management measures to the new IROFS will be completed within 90 days per the ISA Action Plan. Because the revised ISA has designated existing safety controls as additional IROFS, GNF-A is making a report of this completion pursuant to the reporting requirements of 10CFR70 Appendix A(b)(1) within 24 hours."
The NOV inspection report (70-1113/2010-013) was dated June 9, 2010 with an NOV response on July 23, 2010. Milestone #1 was reported in EN #46710 on March 30, 2011. This report concerns milestone #2 of 3.
The licensee will notify the NRC Region 2 Project Manager, the State of North Carolina, and Hanover County.
"In response to a Notice of Violation (NOV), Global Nuclear Fuels - America (GNFA) committed to perform a review of the existing Integrated Safety Analysis (ISA). An ISA Action Plan and schedule for performing the ISA review was described in GNF-A's response to the NOV and the second milestone (fabrication) was scheduled for completion by July 31, 2011. This milestone was subsequently extended by approximately 30 days. On 8/30/11, GNF-A completed the ISA review for the fabrication area and has identified 125 existing safety controls that are now being designated as Items Relied On For Safety (IROFS). Implementation of the revised safety basis, IROFS and application of management measures to the new IROFS will be completed within 90 days per the ISA Action Plan. Because the revised ISA has designated existing safety controls as additional IROFS, GNF-A is making a report of this completion pursuant to the reporting requirements of 10CFR70 Appendix A(b)(1) within 24 hours."
The NOV inspection report (70-1113/2010-013) was dated June 9, 2010 with an NOV response on July 23, 2010. Milestone #1 was reported in EN #46710 on March 30, 2011. This report concerns milestone #2 of 3.
The licensee will notify the NRC Region 2 Project Manager, the State of North Carolina, and Hanover County.
Agreement State
Event Number: 47227
Rep Org: WISCONSIN RADIATION PROTECTION
Licensee: AURORA MEDICAL CTR. OF WASHINGTON CO., INC.
Region: 3
City: HARTFORD State: WI
County:
License #: 131-1024-01
Agreement: Y
Docket:
NRC Notified By: KRISTA KUHLMAN
HQ OPS Officer: HOWIE CROUCH
Licensee: AURORA MEDICAL CTR. OF WASHINGTON CO., INC.
Region: 3
City: HARTFORD State: WI
County:
License #: 131-1024-01
Agreement: Y
Docket:
NRC Notified By: KRISTA KUHLMAN
HQ OPS Officer: HOWIE CROUCH
Notification Date: 08/31/2011
Notification Time: 16:15 [ET]
Event Date: 08/30/2011
Event Time: 00:00 [CDT]
Last Update Date: 08/31/2011
Notification Time: 16:15 [ET]
Event Date: 08/30/2011
Event Time: 00:00 [CDT]
Last Update Date: 08/31/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
MICHAEL KUNOWSKI (R3DO)
GREG SUBER (FSME)
MICHAEL KUNOWSKI (R3DO)
GREG SUBER (FSME)
AGREEMENT STATE REPORT - PATIENT RECEIVED WRONG ISOTOPE DURING A DIAGNOSTIC PROCEDURE
The following information was obtained from the State of Wisconsin via facsimile:
"The Wisconsin Department of Health Services (DHS) received a phone call from the Imaging Manager at Aurora Medical Center of Washington County on August 30, 2011, that a patient received a dose of 5 mCi of I-131 on February 2, 2011. The patient, according to the written directive, was to receive a dose of 5 mCi of I-123. This diagnostic procedure was ordered to evaluate whether any thyroid tissue remained following an iodine ablation dose one year earlier.
"DHS conducted an investigation on August 31, 2011 and the licensee will submit a 15-day written report concerning the medical event. At this time, the licensee is evaluating their process and is developing a new written directive form. The authorized user will discuss this with the referring physician to determine if the patient will be notified."
Wisconsin Report ID: WI110013
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.
The following information was obtained from the State of Wisconsin via facsimile:
"The Wisconsin Department of Health Services (DHS) received a phone call from the Imaging Manager at Aurora Medical Center of Washington County on August 30, 2011, that a patient received a dose of 5 mCi of I-131 on February 2, 2011. The patient, according to the written directive, was to receive a dose of 5 mCi of I-123. This diagnostic procedure was ordered to evaluate whether any thyroid tissue remained following an iodine ablation dose one year earlier.
"DHS conducted an investigation on August 31, 2011 and the licensee will submit a 15-day written report concerning the medical event. At this time, the licensee is evaluating their process and is developing a new written directive form. The authorized user will discuss this with the referring physician to determine if the patient will be notified."
Wisconsin Report ID: WI110013
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.