BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM HEATER COOLER

    MDR report key: 23245028 · Received October 8, 2025

    Report

    Report Number
    MW5177006
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 3, 2025
    Manufacturer
    SPECTRUM MEDICAL, INC.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING CARDIOPULMONARY BYPASS, THE STANDARD HEAT EXCHANGER ON THE PATIENT CIRCUIT HAD GONE DARK, LIKELY INDICATING A BLOOD TO GLYCOL LEAK. WE DEPRIMED THE HEAT EXCHANGER TO PREVENT OR REDUCE THE RISK OF THE LEAK REVERSING TO GLYCOL TO BLOOD. THE PATIENT RECEIVED FOMEPIZOLE AS A PREVENTATIVE TREATMENT. TO NOTE: THE EXCHANGER HAD STARTED REWARMING FROM 32 C TO 37 C ABOUT 15 MINUTES BEFORE THE COLOR CHANGE IN THE HEAT EXCHANGER WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513236 QUANTUM HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SPECTRUM MEDICAL, INC. H000059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R