BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM WORK STATION

    MDR report key: 24468074 · Received February 27, 2026

    Report

    Report Number
    3006073153-2026-00037
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 27, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD.
    Product Code
    DRY
    UDI-DI
    05060434422293
    PMA / PMN Number
    K163657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QWS WAS INSPECTED AFTER THE CASE, BUT THE SPECIFIC SOFTWARE/TOUCHSCREEN GLITCH COULD NOT BE REPRODUCED. DEVICE TO BE INVESTIGATED ON RETURN TO HQ.

    Description of Event or Problem · 0

    DURING REDUCTION OF CPB FLOW TO 1.0 LPM FOR CROSS-CLAMP REMOVAL, THE TOUCHSCREEN FAILED TO RESPOND WHILE DEACTIVATING THE CROSS-CLAMP TIMER. INITIATION MODE WAS INADVERTENTLY ACTIVATED. THE ARTERIAL FLOW CONTROL DIAL DISPLAY SWITCHED TO "VENOUS OCCLUDER," AND ARTERIAL FLOW REMAINED BELOW 1.0 LPM WITH THE CLAMP BEING OPEN. ATTEMPTS TO DEACTIVATE "INITIATION MODE" WERE UNSUCCESSFUL. THE CIRCUIT WAS MANUALLY CLAMPED, THE SURGICAL TEAM WAS NOTIFIED, AND THE CP37 PUMP HEAD WAS PLACED ON EMERGENCY HAND-CRANK TO RESTORE FLOW AND MAP. IN A FINAL ATTEMPT, INITIATION MODE WAS DEACTIVATED SUCCESSFULLY, THE PUMP RETURNED TO EXTERNAL DRIVE, AND THE PATIENT WAS SUCCESSFULLY WEANED FROM CPB. THE QWS WAS INSPECTED AFTER THE CASE, BUT THE SPECIFIC SOFTWARE/TOUCHSCREEN GLITCH COULD NOT BE REPRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530972 QUANTUM WORK STATION EXTRACORPOREAL BLOOD GAS/PH MONITOR DRY SPECTRUM MEDICAL LTD. QWS15 05060434422293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other