BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 14847546 · Received June 28, 2022

    Report

    Report Number
    3007899424-2022-00033
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    December 20, 2021
    Report Date
    May 31, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 CUSTOMER PROVIDED PHOTOS OF THE INTERNAL TUBING AND REQUESTED A REVIEW, DUE TO ITS BROWN DISCOLORATION. THE DEVICE WAS TESTED AND FOUND TO CONTAIN BACTERIAL CONTAMINATION LEVELS THAT EXCEEDED ACCEPTABLE LIMITS. THE DEVICE WENT THROUGH AN INTERNAL WATER PATHWAY REPLACEMENT AND WAS TESTED AFTERWARDS. ACCORDING TO LAB RESULTS, THE CFU COUNT WAS WITHIN THE ACCEPTABLE LIMITS.

    Description of Event or Problem · 0

    CUSTOMER PROVIDED PICTURES OF THE INTERNAL TUBING OF THIS DEVICE FOR REVIEW, UPON WHICH THE DEVICE WAS RECOMMENDED FOR AN INTERNAL TUBING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909374 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown