Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
ACCESSION #: 9603130277
Nucletron - Oldelft Nucletron - Oldelft Corporation
7080 Columbia Gateway Drive
Columbia, Maryland 21046-2133
Telephone: 410-312-4100
Fax: 410-312-4199
March 12, 1996
Director, Office of Enforcement
U. S. Nuclear Regulatory Commission
ATTN: Document Control Desk
Washington, D.C. 20555
Dear Sirs:
The following pages are submitted for your review in compliance with I
10CFR Section 21.21, Report of Defect.
Should you have any questions or concerns in this matter after review of
this information, please feel free to contact the undersigned directly.
Sincerely,
NUCLETRON-OLDELFT CORPORATION
Stephen P. Teague
Director of Regulatory Affairs/R.S.O.
enclosure: Report of Defect
cc: Region III N.R.C. Office
*** END OF DOCUMENT ***
ACCESSION #: 9603130283
PART 21
REPORT OF DEFECT
microSelectron-High Dose Rate Remote
Afterloader
Memorial Medical Center
January 9, 1996
Prepared by:
S. P. Teague
Director of Regulatory Affairs
Nucletron-Oldelft Corporation
In compliance with 10CFR Section 21.21 Nucletron-Oldelft Corporation is
submitting the following report with attachments as listed on the Table
of Contents Page.
Submitted by: Date of Report:
Stephen P. Teague March 12, 1996
Director of Regulatory Affairs
Nucletron-Oldelft Corporation
Facility: Device:
Memorial Medical Center microSelectron-HDR S/N 9003
800 North Rutledge S & D No. MD-497-D-104S
Springfield, IN 62781
Device Supplier: Device Installer:
Nucletron-Oldelft International B.V. Nucletron-Oldelft Corporation
Waardgelder 1 7080 Columbia Gateway Drive
3905 TH Veenendaal Columbia, Maryland 21046
THE NETHERLANDS
Nature of Defect:
See Attached
Initial Notification:
a. By facility January 9, 1996
Installed Base:
See Appendix I (User List)
Corrective Action Plan:
a. Action: Replace defective board
b. Responsible Party Nucletron-Oldelft Corporation
c. Time Schedule Immediate
Final Notification:
a. to facility March 13, 1996
b. to NRC OPS Center March 13, 1996
c. to Regional Office March 13, 1996
d. Maryland State DOE March 13, 1996
Authorization:
The preparation of this report is authorized individual:
Date Stephen P. Teague
Director of Regulatory Affairs
TABLE OF CONTENTS
History of Event
Failure Analysis
Conclusion
Summary
Corrective Action
Appendix I - User List
Appendix II - Safety Alert
I. History of Event
On January 9, 1996, Nucletron-Oldelft Corporation was advised via
telephone by Memorial Medical Center in Springfield, Indiana that the
display failed to update treatment information. The microSelectron-HDR
Treatment Control Unit was unable to display or print current status of
the treatment. The operator responded by pressing the Interrupt button
at that time. The button failed to retract the source. The operator
opened the door to the treatment room. This interlock failed to retract
the source. The operator turned the Emergency hand crank and the source
retracted under machine control. The unit was removed from service
pending the arrival of a Nucletron service engineer. On January 12,
1996, a service engineer on site attempted to duplicate the condition
that existed, without success.
II. Failure Analysis
The system was tested extensively and all functions performed within
normal limits. All door switches and Emergency Stop switches functioned
correctly. The service engineer was unable to duplicate the error
condition. The CPU board was removed for failure analysis by the
manufacturer (supplier). Results of this investigation are not yet
available.
III. Conclusion
The CPU board was replaced and extensive cycling performed. There was no
indication that the problem reoccurred. The unit was returned to the
customer for Quality Assurance testing prior to being placed in clinical
use.
IV. Summary
A microSelectron-HDR failed in the communication between the control unit
and the Treatment Unit. This failure prevented both the Interrupt button
and door interlock switch from retracting the source. The Emergency Stop
button was not pressed by the operator prior to entering the treatment
room.
V. Corrective Action
The CPU board has been shipped to the manufacture for failure analysis.
A Safety Alert has been sent to all North American Users of the
microSelectron-HIDR and microSelectron-PDR devices.
Investigated into redesign of firmware or hardware is ongoing to
prevent door interlock failures due to communication problems.
APPENDIX I "CUSTOMER USER LIST," 6 Pages omitted.
APPENDIX II
Safety Alert
Nucletron - Oldelft Corporation
nucletron - Oldelft 7080 Columbia Gateway Drive
Columbia, Maryland 21046-2133
Telephone: 410-312-4100
Fax: 410-312-4199
March 4, 1996
Dear Nucletron microSelectron HDR & PDR Users:
Your attention is directed to the attached Safety Alert describing a
situation that may occur in routine operation of the device. This alert
is based on an event that occurred recently at a facility using this
device. Please follow the instructions contained in this Alert to
prevent loss of treatment data and potential radiation exposure to
operators.
If you have any questions regarding this Safety Alert or the procedure to
be followed, please call the 1-800 number listed that the bottom of the
Safety Alert.
Sincerely,
NUCLETRON CORPORATION
Stephen P. Teague
Director of Regulatory Affairs
Attachment: Safety Alert # 300.074
nucletron - Oldelft Safety Alert
Validity: mHDR/mPDR
Situation Solution
During normal treatment operation, If the display on the Control
the micro-Selectron HDR and PDR Unit stops updating the status
control unit may freeze up. of the treatment, the operator
The door switch and interrupt is required to perform the
buttons may be inoperative during following steps in sequence:
these situations The printer will
stop printing the record of dwell 1. Depress the Interrupt button,
positions and treatment times and then
delivered....
2. Depress the Master Emergency
Stop button.
3. Note the exact time that the
display stopped and the
Cause condition of all lamps,
keyswitches, and
The exact cause is uncertain at information shown on display.
this time, but is believed to be a
momentary loss of communications 4. Call Nucletron at the number
between the Treatment Unit, and the listed on the Emergency
Control Unit. The Treatment Unit, Procedures sheet posted on the
which has control of the treatment console. DO NOT attempt to
parameters, continues to function reset the system and continue
properly. the treatment.
You will be given instructions in
the proper method of resetting
the Control Unit and continuing
with the treatment. There is no
danger of overexposure to
the patient or operator if the
procedure is followed.
FOR MORE INFORMATION, CONTACT: Tel: 1- 800-445-9295
Nucletron-Oldelft Corporation Fax: (410)-312-4196
Columbia, Maryland, 21046 Issue Date: Mar. 4, 1996
Page 1 of 1 Part 300.074
*** END OF DOCUMENT ***
