BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 14739222 · Received June 17, 2022

    Report

    Report Number
    3007899424-2022-00007
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    February 27, 2018
    Report Date
    May 31, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS REPORTING THE FOLLOWING COMPLAINT AFTER A VOLUNTARY REVIEW OF ALL COMPLAINTS (REPORTABLE OR NOT) SINCE 2016. THIS REPORT IS BEING FILED NOW, AFTER BEING SCRUTINIZED UNDER A NEWLY REVISED RISK MATRIX, RECENTLY ADOPTED AFTER INSPECTION. THE UNIT'S WATER TANK HAD A SHEEN ON THE WATER IN ADDITION TO THE UNIT PRODUCING A BAD SMELL. THE DEVICE MET THE CRITERIA FOR BACTERIAL CONTAMINATION. DURING THE INVESTIGATION, THE PROBLEM WAS TRACED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS OF USING FILTERED 0.22-MICRON WATER OR STERILE WATER TO PREVENT CONTAMINATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THE UNIT IS GIVING OFF A BAD SMELL, AND THE PERFUSION IS REPORTING THAT THE UNIT'S WATER TANK HAS A SHEEN ON THE WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194216 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown