BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM WORKSTATION ELITE

    MDR report key: 20598596 · Received November 4, 2024

    Report

    Report Number
    3006073153-2024-00090
    Event Type
    Death
    Date Received
    November 4, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 4, 2024
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434422309
    PMA / PMN Number
    K202557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT WAS PLACED ON ECMO ON THE SEPTEMBER 30TH, AT APPROX 2:15 AM, AND TRANSPORTED TO CTICU WHERE THE EQUIPMENT WAS PLUGGED INTO THE WALL OUTLET AND GAS LINES WERE HOOKED UP TO THE WALL GAS SOURCE. AT THIS POINT EVERYTHING WAS OPERATING CORRECTLY, AND THE PATIENT SEEMED RELATIVELY STABLE WHILST RECEIVING BLOOD FOR A CONCERN OF POSSIBLE VOLUME LOSS. AT 5:03 AM THE PERFUSIONIST RECEIVED A PHONE CALL FROM A NURSE WHO SAID THAT THE PATIENT WAS TO HAVE THEIR CHEST OPENED AT BEDSIDE AND THAT A CELL SAVER WAS REQUIRED. THEY ALSO SAID THAT THE PUMP WAS OFF AND THEY ESTABLISHED THAT THE WORKSTATION AND THE VENTILATION MODULE WERE ALSO OFF. THE BLOOD IN THE CIRCUIT APPEARED DARK. THE NURSE WAS UNABLE TO DETERMINE HOW LONG THE SYSTEM HAD BEEN OFF FOR AT THAT POINT. SHE PROCEEDED TO CONNECT THE GAS LINE DIRECTLY TO THE O2 TANK AND SET THE SWEEP TO 1 L/MIN. WHEN THE PERFUSIONIST JOINED THEM, THE EMERGENCY HAD BEGUN AND THE SWEEP CONTINUED TO BE SET AT 1 L/MIN, THE PERFUSIONIST CHANGED IT TO THE PREVIOUS SETTING OF 3 L/MIN AND TRIED TO RECOVER THE OLD CASE. THE PERFUSIONIST POWERED THE WORKSTATION AND THE VENTILATION MODULE OFF AND REBOOTED, AFTER WHICH THEY WERE ABLE TO FIND THE PROPER CASE IN THE RECOVERY SECTION. THEY RESET ALL THE SAFETY PARAMETERS ON THE VENTILATION MODULE. THE PATIENT WAS OPENED AND HAD SUBSTANTIAL BLOOD LOSS. A CELL SAVER WAS ALSO USED DURING THE EFFORTS TO SAVE THE PATIENT. THE CLINICAL TEAM ATTEMPTED TO RUSH THE PATIENT TO THE OR, BUT THE SITUATION WAS DEEMED UNRECOVERABLE DUE TO MASSIVE BLOOD LOSS AND INABILITY TO GET RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774805 QUANTUM WORKSTATION ELITE PATIENT MONITOR DRY SPECTRUM MEDICAL LTD QWS12E 05060434422309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death