BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 19367869 · Received May 21, 2024

    Report

    Report Number
    3007899424-2024-00070
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 16, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER INFORMED CARDIOQUIP THAT INTERNAL TESTING UNCOVERED NTM IN THEIR DEVICE. THIS IS OUTSIDE OF CARDIOQUIP'S SPECIFICATIONS FOR WATER QUALITY. THE CUSTOMER WAS INFORMED OF CARDIOQUIPS RECOMMENDED REMEDIATION OPTIONS, THESE INCLUDE, (1) THE CUSTOMER REPERFORM CLEANING AND DISINFECTION PROCEDURES DETAILED IN THE IFU AND REPERFORM HPC TESTING, (2) HAVE THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT OR, (3) PARTICIPATE IN CARDIOQUIP'S TRADE IN PROGRAM. ALL OF THESE OPTIONS WOULD RETURN THE DEVICE TO SPECIFICATION AND FULL FUNCTIONALITY. AS OF THE DATE OF THIS REPORT THE CUSTOMER HAS NOT RESPONDED TO THESE OPTIONS.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED STATING THE HOSPITAL'S IN-HOUSE WATER QUALITY TESTING UNCOVERED NTM IN THE DEVICE. PER THE CUSTOMER ON (B)(6) 2024, THE HOSPITAL SAMPLED THE WATER SOURCE ABOUT A MONTH AGO. TEST RESULTS CONFIRMED THE DEVICES WATER QUALITY WAS OUTSIDE OF CARDIOQUIP SPECIFICATIONS ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570647 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown