BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM HEATER COOLER

    MDR report key: 20093692 · Received August 29, 2024

    Report

    Report Number
    3006073153-2024-00041
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Report Date
    August 14, 2024
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DWC
    PMA / PMN Number
    K212567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS HCU STARTED TO GO THROUGH AN UPDATE THIS MORNING, THE USER WAS ALARMED BECAUSE THEY WERE GETTING CLOSE TO GOING ON BYPASS SO SHE UNPLUGGED THE HCU FROM THE QWS. SHE CONTINUED TO USE THE HEATER COOLER, THEN IT POPPED UP WITH A CONTACT SERVICE ALERT DURING THE CASE. THEY SWAPPED IT BECAUSE IT WOULDN'T COOL AND NOW THEY ARE GETTING ALARM CODE: 143 AND IT WILL NOT PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269398 QUANTUM HEATER COOLER HEATER COOLER DWC SPECTRUM MEDICAL LTD QHC1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown