Event Notification Report for July 16, 2013

AGREEMENT STATE REPORT - UNDERDOSE TO PATIENT DUE TO EQUIPMENT FAILURE

The following information was obtained from the State of New Jersey via email:

"At 11:30 a.m. [EDT] on July 16, 2013, a patient was being treated for three lesions with an Elekta Leksell Gamma Knife Perfexion unit, serial number 6016, at Cooper Health System in Camden, New Jersey. The prescribed total dose for all three lesions was 58 Gray.

"The first two lesions were treated as planned without incident.

"During treatment of the third lesion, treatment was interrupted because of mechanical failure. A 'Sensor Failure' error occurred, which caused the patient couch to retract and the shielding doors to close. An Elekta service engineer was called and no other treatments were attempted after the 'Sensor Failure'. Treatment of the third lesion was to be re-scheduled.

"It is estimated that only 44.8 Gray out of the prescribed dose of 58 Gray was actually delivered, which is an underdose of greater than 20%."

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.

PART 21 FIRMWARE NOTICE FOR USERS OF YOKOGAWA DX1000N AND DX2000 MODEL RECORDERS

"This letter is to inform you of a potential Yokogawa data recorder lock-up condition that under specific circumstances may occur on Yokogawa DX Advanced DX1000N and DX2000 models equipped with firmware versions 3.01 through 4.14. These recorders were bought commercially from Yokogawa by National Technical Systems (NTS) and dedicated as basic components for nuclear safety related service.

"The lock-up condition only impacts recorders when utilizing a 'custom trend display' option. There is no lock-up concern with these models when standard display screens are in use or on models using firmware versions earlier than R3.01. While NTS has not received any notification this lock-up condition occurred on a safety related recorder, please see the below description of the error and the appropriate corrective measures.

"Background:
Public Service Electric and Gas - Hope Creek NPP notified NTS and Yokogawa of a lock up condition which occurred on a newly installed non-safety data recorder in their simulator. Yokogawa studied the condition and notified NTS on June 14, 2013 that a firmware error occurs during a specific set of operating conditions and sequence of events and was identified as the root cause of the recorder lock up condition. While these conditions are highly unlikely in an operating plant because under normal practice the internal memory on the recorder would not be cleared, the recorder will lock-up if the below setup conditions occur simultaneously:

"1. A 'Custom Display' that uses a trend screen is active and visible.
2. There is no trend data stored in memory (blank trend screen); this is the condition following a 'Clear 3' initialize.
3. A 'Second Speed' function is invoked via remote input activation (requires / R1 option) or front panel key activation. This is called 'Trend rate switching' a function enabled in Basic Setting Mode that allows the trend update time/division to switch between two separate speeds.

"Corrective Action:
This error only affects recorders if 'Custom Display' is being utilized. If this feature is not being used, no immediate action needs to be taken. If custom screens exist, then please utilize the recommendations below and update firmware when the new version (4.19) becomes available in August 2013.

"A short-term countermeasure is to follow the Yokogawa operational procedure of starting to record data immediately after invoking a 'Clear 3' initialize, and then waiting for at least one trend update to occur (Display data save) before invoking a 'Second Speed' change action.

"Should a lock-up condition occur, as indicated by a freeze of the display clock, the recorder simply needs to be powered off and re-started. The recorder will continue to function properly.

"Based on the above, the nuclear utilities need to be notified concerning this deviation so an evaluation may be performed to determine if this constitutes a defect that could create a substantial safety hazard. NTS cannot make this determination as only the effected utilities know the way the recorders are configured and utilized.

"The attached list contains the nuclear power plants which have been provided DX Advanced safety related Yokogawa recorders with firmware versions 3.01 and above by NTS. NTS has notified these utilities of the above condition via e-mail on July 16, 2013.

"CENG - Nine Mile
Dominion - Surry Station
Dominion - North Anna
Entergy - Arkansas Nuclear One
Entergy - Fitzpatrick
Entergy - Pilgrim Nuclear Station
Entergy - River Bend
Exelon - Braidwood Warehouse
Exelon - Byron
Exelon - Dresden Station
Exelon - Limerick Generating Station
Exelon - Quad Cities
First Energy - Perry Plant
Florida Power & Light - St. Lucie
Georgia Power - Vogtle Plant
AEP - DC Cook
Nebraska Public Power - Cooper
NextEra Energy - Duane Arnold
Omaha PPD - Fort Calhoun
Entergy - Palisades
Progress Energy - H.B. Robinson Plant
PSE&G - Salem/Hope Creek
Edison - San Onofre
STP Nuclear Operating Company
TVA - Sequoyah Station
Wolf Creek Nuclear Operating Corp.
Xcel Energy - Prairie Island Nuclear"