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Event Notification Report for December 12, 2011

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
12/11/2011 - 12/12/2011

** EVENT NUMBERS **


47503 47506 47507 47517 47520

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Agreement State Event Number: 47503
Rep Org: NV DIV OF RAD HEALTH
Licensee: NEVADA HEART AND VASCULAR CENTER
Region: 4
City: LAS VEGAS State: NV
County:
License #: 03-12-0453-01
Agreement: Y
Docket:
NRC Notified By: SNEHA RAVIKUMAR
HQ OPS Officer: STEVE SANDIN
Notification Date: 12/06/2011
Notification Time: 12:24 [ET]
Event Date: 03/08/2011
Event Time: [PST]
Last Update Date: 12/06/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
NEIL OKEEFE (R4DO)
JAMES DANNA (FSME)

Event Text

AGREEMENT STATE REPORT - POTENTIAL MEDICAL EVENTS INVOLVING CARDIOGEN-82 RADIOISOTOPE GENERATORS USED FOR CARDIAC STRESS TESTING

The following information was received from the State of Nevada via email:

"Description: A patient who received a Rubidium stress test on March 8th 2011 was detected at a security checkpoint upon reentry to the United States. The patient was determined to have higher than expected levels of strontium. The patient was referred to Oak Ridge National Laboratory to undergo sensitive whole body counting. The whole body counting indicated an expected dose of 4.9 rem. Additional testing conducted by the Nevada Radiation Control Program was performed on 203 patients. The result of each scan was compared to the patient who received the whole body counting at Oak Ridge National Laboratory. The definition of a medical event is '[a] dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem)' and that 'differs from the prescribed dose by 20 percent or more.' [10 CFR 35.3045]. Because the patient who received the whole body counting at Oak Ridge received 4.9 rem any patient who had more activity when compared to the Oak Ridge patient may qualify as a medical event. The analysis of the scans indicates 38 patients had an exposure that may constitute a medical event. The following table identifies the date, number of patients on a specific date, and the total number of patients that may have received Sr-82 and Sr-85 in sufficient quantities to constitute a medical event. The investigation is ongoing and includes the Nevada Radiation Control Program, Food and Drug Administration ('FDA'), BRACCO, and Nevada Heart and Vascular. As information becomes available the actual number of medical events may change and will be updated at that time.

"Date Of Injection # Of Patients

2/11/2011 6
3/7/2011 2
3/8/2011 5
3/9/2011 3
3/10/2011 5
3/11/2011 2
3/12/2011 3
3/13/2011 4
3/14/2011 1
3/15/2011 2
4/5/2011 1
4/7/2011 4

Total Patients 38

"Why The Event Occurred: The events are still under investigation. The events may be related to manufacturing defects, inadequate training procedures, or a combination of both. 'Based on further investigation, FDA has determined that the current CardioGen-82 manufacturing procedures are not sufficient to ensure reliable performance of the generator used to produce the Rb-82 chloride injection' (FDA, 7-26-2011).

"The Effect, if any, on the Individuals Who Received the Administration: The exposure is still under investigation. However, no deleterious effects are expected as a result to the exposure. Concerning this issue, 'Oak Ridge National Laboratory determined the estimated amount of unexpected radiation to be minimal and similar to what other patients may receive with cumulative exposure to certain other types of cardiac imaging procedures' (Giordano, K. & McDaniel, K., 2011).

"What Actions, if any, Have Been Taken, or are Planned to Prevent Recurrence: The FDA alerted healthcare professionals to stop use of CardioGen-82 for Cardiac PET scans and BRACCO decided to voluntarily recall CardioGen-82 and this will prevent recurrence. (FDA, 7-26-2011). In addition, all technologists have undergone retraining by BRACCO and shall adopt BRACCO's updated policy concerning breakthrough testing. An online worksheet has been constructed to simplify and monitor the breakthrough recording process.

"Additional actions may be implemented based on the investigation's findings.

"Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

"All patients who received studies on the dates referenced above have met with their referring physician concerning the elevated exposure to strontium. This is included in the patient's chart as part as their medical record. The Nevada Radiation Control Program has also contacted patients concerning the elevated strontium exposure.

"Event Cause: Equipment Failure

"Corrective Action: Reevaluation of CardioGen-82 design, training procedures and quality control.

"Device/Associated Equipment: CardioGen-82 manufactured by BRACCO Diagnostics."

NV Report No.: NV110023

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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Agreement State Event Number: 47506
Rep Org: PA BUREAU OF RADIATION PROTECTION
Licensee: ALLEGHENY LUDLUM STEEL PLANT; BAGDAD PLANT
Region: 1
City: LEECHBURG State: PA
County:
License #: PA-G0114
Agreement: Y
Docket:
NRC Notified By: DAVID ALLARD
HQ OPS Officer: CHARLES TEAL
Notification Date: 12/07/2011
Notification Time: 09:59 [ET]
Event Date: 12/07/2011
Event Time: [EST]
Last Update Date: 12/07/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
CHRISTOPHER CAHILL (R1DO)
ANGELA MCINTOSH (FSME)

Event Text

AGREEMENT STATE - SHUTTER FAILURE

The following was received from the Commonwealth of Pennsylvania via facsimile:

"On December 6, 2011, the Department's Southwest Regional Office [Pennsylvania Bureau of Radiation Protection (PBRP)] received notification via email about an event that took place on December 2, 2011. It is reportable within 24 hours under 10 CFR 30.50(b)(2).

"A radiological consultant was completing the six month leak testing and shutter checks of thickness gauges. During the testing, it was discovered that the pneumatic system for this gauge did not completely close the shutter. The device is identified as:

Manufacturer: DMC
Model: AM-5A
Serial #: 0404LV
Isotope: Am-241
Activity: 100 mCi

"CAUSE OF EVENT: Failure of the pneumatic system to completely close the shutter.

"ACTIONS: Maintenance personnel were able to drain the air line of accumulated moisture and close the shutter later that day. The Bagdad facility shall investigate this matter and determine what is necessary to prevent recurrence. The Department [PBRP] plans to conduct a reactive inspection."

Event Report ID No: PA11039

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Agreement State Event Number: 47507
Rep Org: KENTUCKY DEPT OF RADIATION CONTROL
Licensee: TEMPLE-INLAND
Region: 1
City: MAYSVILLE State: KY
County:
License #: 401-531-10
Agreement: Y
Docket:
NRC Notified By: MARRISA VELEZ
HQ OPS Officer: JOHN KNOKE
Notification Date: 12/07/2011
Notification Time: 15:40 [ET]
Event Date: 04/10/2010
Event Time: 21:00 [CST]
Last Update Date: 12/07/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
CHRISTOPHER CAHILL (R1DO)
JAMES DANNA (FSME)

Event Text

AGREEMENT STATE REPORT - SHUTTER SOLENOID FAILURE ON GAUGE

The following report was received from the Kentucky Department of Public Health - Radiation Health Branch via facsimile:

"The state (Kentucky Radiation Health Branch) was notified on 4/12/10, by a representative from Temple-Inland, of the failure in the shutter (in the closed position) on one of their gauges. The gauge is a Honeywell, Model 4000, scanner (Honeywell system number 8465) containing a 1 Ci Kr-85 source, model number 4201, serial number 4991BXV. This event occurred on the evening of 4/10/10 and a representative from Honeywell was called in for repair. The scanner was back online at 2349 CST on 4/10/10 for a total downtime of 2.25 hours."

Kentucky Report ID Number: KY1007

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Power Reactor Event Number: 47517
Facility: SALEM
Region: 1 State: NJ
Unit: [1] [ ] [ ]
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: THOMAS BYYKKONEN
HQ OPS Officer: JOHN KNOKE
Notification Date: 12/11/2011
Notification Time: 16:45 [ET]
Event Date: 12/11/2011
Event Time: 12:58 [EST]
Last Update Date: 12/11/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(v)(A) - POT UNABLE TO SAFE SD
Person (Organization):
CHRISTOPHER CAHILL (R1DO)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
1 N Y 100 Power Operation 100 Power Operation

Event Text

INTERMEDIATE RANGE NUCLEAR INSTRUMENT HIGH FLUX TRIP SET POINTS SET INCORRECTLY

"This 8 hour notification is being made in accordance with 10 CFR50.72 (b)(3)(v)(A).

"On November 24, 2011, 1N35 and 1N36 Intermediate Range Nuclear Instruments High Flux Trip set points were adjusted while Unit 1 was at approximately 55% reactor power following the 1R21 Refueling outage, On December 11, 2011, at 1258 EST Salem Unit 1 entered Technical Specification 3.0.3, after determining the set points were set incorrectly.

"A review of the Reactor Engineering Manual, which contains the trip set points, showed that the trip set points for 1N35 and 1N36 were 2.69E-4 and 2.37E-4 respectively. These values equate to approximately 125% thermal power. The Intermediate Range Trip set point is normally set to 25% thermal power. Both channels were declared inoperable and preparations were made to install the correct set points. At 1628 [EST] 1N35 was declared operable and Technical Specification 3.0.3 was exited following installation of the correct set point and retest of the channel.

"There was no out-of-service safety related equipment that contributed to this event. No one was injured as a result of this event."

The licensee will notify the NRC Resident Inspector and local authorities.

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Power Reactor Event Number: 47520
Facility: OYSTER CREEK
Region: 1 State: NJ
Unit: [1] [ ] [ ]
RX Type: [1] GE-2
NRC Notified By: JIM RICHIE
HQ OPS Officer: JOHN KNOKE
Notification Date: 12/12/2011
Notification Time: 18:06 [ET]
Event Date: 12/12/2011
Event Time: 16:50 [EST]
Last Update Date: 12/12/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(2)(xi) - OFFSITE NOTIFICATION
Person (Organization):
HAROLD GRAY (R1DO)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
1 N Y 100 Power Operation 100 Power Operation

Event Text

OFFSITE NOTIFICATION TO STATE OF NEW JERSEY DUE TO HIGH OPACITY OF DIESEL EXHAUST

"At 1447 [EST] Oyster Creek experienced a failure of a discharge flange on a fire protection pond pump. The fire system backup fire diesel started in response to low system pressure. At 1540 [EST], it was noted that the fire diesel had higher than expected opacity from its exhaust. High exhaust opacity (equal to or greater than 20% for more than 3 minutes in any consecutive 30 minute period) is reportable to the State of New Jersey in accordance with the Auxiliary Boiler Air Pollution Control Permit. At 1650 [EST], high opacity from the fire diesel was reported to the State of New Jersey via the NJ Department of Environmental Protection hotline.

"In accordance with 10 CFR 50.72 (b)(2)(xi) this event is being reported due to Offsite Notification."

The licensee has notified the NRC Resident Inspector.

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Tuesday, August 11, 2015