BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM HEATER COOLER

    MDR report key: 20853647 · Received December 5, 2024

    Report

    Report Number
    3006073153-2024-00125
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    May 16, 2023
    Report Date
    November 25, 2024
    Manufacturer
    SPECTRUM MEDICAL LIMITED
    Product Code
    DWC
    PMA / PMN Number
    K212657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED TO SPECTRUM MEDICAL LTD FOR REWORK TO THE LATEST BUILD. THE ORIGINAL ERROR WAS NOT POSSIBLE TO REPLICATE.

    Description of Event or Problem · 0

    THE HEATER COOLER WAS NOT ADEQUATELY COOLING THE HEAT TRANSFER FLUID TO THE SET TEMPERATURE. THE DEVICE PRODUCED AN ALARM CODE, BUT THE USER WAS UNABLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114451 QUANTUM HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SPECTRUM MEDICAL LIMITED QHC2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown