Part 21 Report - 1996-330

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 ***

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