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Event Notification Report for August 10, 2007

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
08/09/2007 - 08/10/2007

** EVENT NUMBERS **


43378 43558

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General Information or Other Event Number: 43378
Rep Org: WASHINGTON HOSPITAL CENTER
Licensee: BEST VASCULAR, INC.
Region: 1
City: WASHINGTON State: DC
County:
License #:
Agreement: N
Docket:
NRC Notified By: S. MOHAPATRA
HQ OPS Officer: JEFF ROTTON
Notification Date: 05/21/2007
Notification Time: 15:08 [ET]
Event Date: 03/23/2007
Event Time: [EDT]
Last Update Date: 08/09/2007
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21 - UNSPECIFIED PARAGRAPH
Person (Organization):
EUGENE COBEY (R1)
SCOTT MOORE (FSME)

Event Text

PART 21 DEFECT - BRACHYTHERAPY SEEDS UNABLE TO RETURN TO TRANSFER DEVICE AFTER TREATMENT

"Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect:

"Facility: Washington Hospital Center;
"Activity: IVRT using a Beta Cath System.

"Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect:

"Best Vascular, Inc. (formerly known as Novoste Corporation).

"Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply:

"The patient is treated with beta radiation using the Beta Cath device. For the treatment, the sources are monitored and confirmed in the correct treatment position by fluoroscopy. At the completion of treatment, sometimes the seeds are unable to return to the transfer device. Therefore, the beta-rail catheter with all the seeds in it is taken out immediately and placed in the bail out box. The box is then transported back to the storage area. Patient and the area are surveyed to ensure that they are free from all radiation sources. The patient receives the full dose as prescribed. No additional or unnecessary dose is delivered to the patient. There were no medical events. The hospital's Radiation Safety Officer and Best Vascular (Novoste) are notified when this incident occurs. A faulty device is returned to the manufacturer and not used on patients. An incident report is filed for each incident. The device with the catheter is shipped back to Best Vascular for disposal and a new replacement source is requested. The incident is deemed as equipment malfunction. It is an inherent problem with the device itself.

"The date on which the information of such defect or failure to comply was obtained:

"2007: 1/18/07, 2/12/07, 3/7/07 and 3/23/07
"2006: 9/7/06, 11/6/06
"2005: 2/18/05, 4/8/05, 4/14/05, 8/3/05, 10/6/05

"In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in this part:

"The device consists of a hydraulic system and it fails while retracting the sources after the treatment is complete. It happens for both 60 mm and 40 mm devices that we currently use.

"The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action:

"Corrective Action: The licensee always followed the manufacturer's emergency procedure.
"Organization: Washington Hospital Center

"Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees:

"Recommend the vendor to perform an extensive QC test before shipping the device to the customer. It may reduce the number of occurrences."

* * * UPDATE FROM MOHAPATRA TO HUFFMAN AT 13:29 EDT ON 8/9/07 * * *

The licensee was performing another IVRT (Intravascular Radiation Treatment) today (8/9/07 at 10:35 EDT) when the Brachytherapy device failed to retract. The device was using a 60 mm catheter with 24 Strontium-90 seeds. As noted above, the licensee uses a Beta Cath System that were originally supplied by Novoste Corp and are now serviced under Best Vascular, Inc. The catheter with the seeds were immediately removed and placed in a "bail-out" box. The device with the catheter and seeds will be returned to the manufacturer. There was no exposure issue or medical event as a result of this malfunction.

This report is being made to document continued problem with this device as noted in the previous report. The licensee plans to contact the NRC Regional Inspector (Gabriel) about this event. The R1DO ( Summers) and FSME (Zelac) were notified.

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Power Reactor Event Number: 43558
Facility: OCONEE
Region: 2 State: SC
Unit: [1] [2] [3]
RX Type: [1] B&W-L-LP,[2] B&W-L-LP,[3] B&W-L-LP
NRC Notified By: RANDY TODD
HQ OPS Officer: JOHN MacKINNON
Notification Date: 08/09/2007
Notification Time: 10:41 [ET]
Event Date: 08/07/2007
Event Time: 16:00 [EDT]
Last Update Date: 08/09/2007
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21 - UNSPECIFIED PARAGRAPH
Person (Organization):
RANDY MUSSER (R2)
VERN HODGE (NRR)
JOHN THORP (NRR)

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 Y 100 Power Operation 100 Power Operation
3 N Y 100 Power Operation 100 Power Operation

Event Text

PART 21 - TWO COMMERICAL GRADE RELAYS CONTAINED DEFICIENCIES


" Event: On August 7, 2007, Duke Energy (Duke) completed a reportability determination which concluded that two relays contained deficiencies and were reportable under Part 21. The relays were Commercial Grade Items dedicated by Duke. Following dedication, a bench test performed on August 26, 2004 revealed that relay contacts were not set up properly at the factory. Eight other relays from the same purchase order were acceptable. The relays were Magnecraft Struthers-Dunn part number 219ABAP-115/125D. The Part 21 evaluation in 2004 was terminated based on incorrect guidance in the applicable Duke administrative directive. The directive error was identified March 29, 2007 and a review of prior Part 21 reportability determinations was initiated. The original 2004 problem report on these relays was reopened, leading to this Part 21 report being made at this time.

"Initial Safety Significance: None. The defective relays were never installed. The intended applications could not have resulted in a significant safety hazard. However, the Duke administrative directive on Part 21 evaluations states that all potential applications where the component might be installed as a substitute must be considered. Duke has concluded that installation in some unspecified application 'could have resulted in a significant safety hazard' and therefore the issue is being reported.

"Corrective Action(s): In 2004: There were eight (8) additional relays from the same purchase order. These were retested and found acceptable. The two identified defective relays were returned to the manufacturer. The manufacturer concluded that the relay contacts were improperly assembled. They consider this an isolated case. In 2007: The Duke administrative directive on Part 21 evaluations was corrected. Previous Part 21 determinations were reviewed, leading to this report."


NRC Resident Inspector was notified of this Part 21 notification by the licensee.

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