BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYSTEM,ILLUMENA,NON-OEM

    MDR report key: 15868718 · Received November 28, 2022

    Report

    Report Number
    1518293-2022-00019
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    October 12, 2022
    Report Date
    October 31, 2022
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY- OVERALL INVESTIGATION SUMMARY IMPACT ASSESSMENT SUMMARY A COMPLAINT WAS RECEIVED ON ILLUMENA INJECTOR 900006 SERIAL NUMBER (B)(4) ALLEGING THE INJECTOR WAS ENABLED AND READY TO INJECT BUT DIDN'T START WHEN THE OPERATOR PRESSED THE START BUTTON ON THE REMOTE HAND SWITCH. THE OPERATOR THEN MANUALLY TURNED THE MANUAL KNOB ON THE POWERHEAD TO DELIVER THE CONTRAST MEDIA AND COMPLETE THE CASE. AFTER THE CASE, THE FACILITY BIOMED DISCOVERED THAT THE HAND SWITCH CABLE WAS NOT PROPERLY CONNECTED TO THE POWER PACK. AFTER PROPERLY PLUGGING IN THE HAND SWITCH CABLE, THE HAND SWITCH WOULD THEN START THE INJECTOR. THERE WAS NO DEFECT OR MALFUNCTION OF THE INJECTOR. THE PROBLEM WAS THAT THE REMOTE HAND SWITCH WAS NOT PROPERLY CONNECTED. THE OPERATOR USED THE MANUAL KNOB TO ADVANCE THE RAM AND COMPLETED THE CASE. THERE WERE NO REPORTED INJURY TO PATIENT OR STAFF. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS NO RELATED ISSUES WITH THIS INJECTOR. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY- (B)(4) PROCESS/METHODS - INCORRECT CUSTOMER SETTINGS. ROOT / PROBABLE CAUSE SUMMARY- REFER TO INVESTIGATION SUMMARY. AS SERVICE FOUND NOTHING WRONG WITH THE DEVICE DURING INVESTIGATION, NO CORRECTIVE ACTION WAS POSSIBLE. ALTHOUGH NO ADDITIONAL CAPA IS REQUIRED AT THIS TIME, GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEW MEETINGS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY- UNIT REMAINED IN SERVICE

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2022. THE REPORTER STATES THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO OUR HOSPITAL FOR TREATMENT DUE TO FOCAL CEREBRAL CONTUSION WITH BLEEDING, AND THE PATIENT WAS ADMITTED TO THE INTERVENTION CENTER FOR WHOLE CEREBRAL ANGIOGRAPHY, AND VASCULAR CONTRAST AGENT WAS INJECTED AT HIGH PRESSURE BY THE NURSE TO THE PATIENT, USE THIS HIGH-PRESSURE INJECTOR FOR THE INJECTION, AND NO REDUCTION IN THE INJECTION SOLUTION AFTER PRESSED THE AUTOMATIC INJECTION SWITCH, FAILED AFTER REPEATED PRESSING, IN ORDER NOT TO AFFECT THE PATIENT'S SURGICAL TREATMENT, THE NURSE ROTATED THE BOTTOM KNOB OF THE HIGH-PRESSURE INJECTOR AND INJECTED IT MANUALLY, AND THE FOLLOW-UP TREATMENT WAS NORMAL. AFTER THE END, THE ENGINEER OF THE CLINICAL MEDICAL ENGINEERING DEPARTMENT WAS NOTIFIED, AND THE ENGINEER DISASSEMBLED THE MACHINE AND FOUND THAT THE AUTOMATIC INJECTION SWITCH WAS IN POOR CONTACT, AND IT COULD BE USED NORMALLY AFTER REINSERTING AND UNPLUGGING. CHECK THE INSTRUCTION MANUAL AND NAMEPLATE AND COULDN'T FIND THE EXPIRATION DATE OR USEFUL LIFE. THERE WERE NO REPORTED INJURY TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125044 BASE SYSTEM,ILLUMENA,NON-OEM BASE SYSTEM,ILLUMENA,NON-OEM DXT LIEBEL-FLARSHEIM 900006 C0316C683R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown