BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM WORKSTATION 12" ELITE

    MDR report key: 19948748 · Received August 9, 2024

    Report

    Report Number
    3006073153-2024-00039
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 9, 2024
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434422309
    PMA / PMN Number
    K202557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENTS OCCURRED DURING THE 1500 HOUR AS FOLLOWS: 1. ECMO SPECIALIST NOTICED NEGATIVE ART FLOW IN PARALLEL WITH ECMO PRIMER NOTICING BACKWARD FLOW 2. PATIENT CLAMPED OFF IMMEDIATELY - HAND CRANKING RESUMED 3. CLINICIANS STARTED TROUBLESTHOOTING A. RESET QWS - TRIED GETTING SWEEP GAS TO CONNECT TO TANKS BUT WAS RUNNING SHORT ON TUBING, SO DID NOT DO A HARD RESET FROM THE BOTTOM OF THE FRAME B. WENT INTO ADMIN MODE TO ENSURE THEY HAD COUNTERCLOCKWISE SELECTED, SWAPPED TO CLOCKWISE, UNCLAMPED, NO CHANGE. WENT BACK TO COUNTERCLOCKWISE, NO CHANGE. C. SWAPPED OUT ROLLER PUMP UNIT WHILE REMAINING ON SAME FRAME/QWS/QVM D. REGAINED FORWARD COUNTERCLOCKWISE FLOW 4. RED HERRING - THIS WAS IMMEDIATELY AFTER A RACEWAY WALK AND PRIOR TO STARTING, SPECIALIST TURNED DOWN FLOW TO "OFF", THERE WAS STILL A WHIFF GOING THROUGH SO PRIMER TAPPED THE STOP BUTTON (PRIOR TO LIFTING LID), SCREEN NOTIFICATION POPPED UP AND SPECIALIST QUICKLY TAPPED YES. THE CLINICIANS TROUBLESHOT TOGETHER AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561401 QUANTUM WORKSTATION 12" ELITE MONITOR/CONSOLE DRY SPECTRUM MEDICAL LTD QWS12E 05060434422309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown