BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 14755178 · Received June 21, 2022

    Report

    Report Number
    3007899424-2022-00026
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    November 27, 2020
    Report Date
    June 2, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 DEVICE WAS FOUND TO BE CONTAMINATED WITH M. ABSCESSUS (10 CFU/ML), M. GORDONAE (4 CFU/ML), AND M. CHIMAERA/INTRACELLULARE (1 CFU/ML). HOWEVER, THE CUSTOMER CEASED COMMUNICATION AND AN INITIAL INVESTIGATION WAS NOT POSSIBLE DUE TO THE LACK OF ACCESS TO THE DEVICE.

    Description of Event or Problem · 0

    CUSTOMER SENT WATER SAMPLES TO AN INDEPENDENT LAB TO FIND OUT WHAT THEY WOULD CULTURE. AFTER RECEIVING THE LAB RESULTS BACK, IT WAS DETERMINED THAT THE DEVICE WAS CONTAMINATED WITH M. ABSCESSUS (10 CFU/ML), M. GORDONAE (4 CFU/ML), M. CHIMAERA/INTRACELLULARE (1 CFU/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894966 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown