BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER COOLER DEVICE

    MDR report key: 19208698 · Received April 26, 2024

    Report

    Report Number
    MW5154406
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 20, 2024
    Report Date
    April 25, 2024
    Manufacturer
    CARDIOQUIP
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BASED ON THE GUIDANCE RECEIVED FROM THE FDA LETTER TO HEALTHCARE PROVIDER, "POTENTIAL RISK OF INFECTION DURING CARDIAC SURGERY WHEN USING THE CARDIOQUIP MODULAR COOLER-HEATER DEVICE" DATED SEPTEMBER 30TH, 2020 AND DEVICE CONCERNS RAISED IN THE LETTER, WE ARE SUBMITTING A VOLUNTARY REPORT. ON 3/20/24 (B)(6) MEDICAL CENTER IDENTIFIED BIOBURDEN ON THE CARDIOQUIP MACHINE. THE MACHINES WERE REMOVED IMMEDIATELY FROM USE AND SEQUESTERED WHILE THE MACHINES WERE EVALUATED FOR CONTAMINATION BY THE MANUFACTURER BY HETEROTROPHIC PLATE COUNT (MICRO CULTURE). LAB CULTURES RESULTED IN 507,000 MPN/ML WHICH IS WELL ABOVE THE ACCEPTED VALUE OF <100 MPN/ML. THE MACHINE UNDERWENT FULL ANNUAL PREVENTIVE MAINTENANCE AND SANITATION WITH MANUFACTURER'S APPROVED DISINFECTANT AND RE-CULTURED. THE RE-CULTURE RETURNED WITHIN NORMAL LIMITS AND THE MACHINE WAS APPROVED TO BE RETURNED BACK TO SERVICE. NO PATIENTS WERE EXPOSED AND NO GAPS HAVE BEEN IDENTIFIED WITH MAINTENANCE AT THIS POINT IN TIME BUT A GAP ANALYSIS IS UNDERWAY. THE SERIAL NUMBER FOR THE UNIT IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172753 HEATER COOLER DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CARDIOQUIP MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 149 YR Prefer Not To Disclose