BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 18321780 · Received December 13, 2023

    Report

    Report Number
    3007899424-2023-00472
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 20, 2023
    Report Date
    July 26, 2024
    Manufacturer
    CARDIOQUIP LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE UNDERWENT TESTS FOR WATER QUALITY, TO ASSESS BACTERIAL CONTAMINATION. FOLLOWING TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THIS WOULD RETURN THEIR DEVICE TO SPECIFICATION AND FULL FUNCTIONALITY. THE CUSTOMER COULD ALSO PARTICIPATE IN CARDIOQUIP'S TRADE IN PROGRAM AND RECEIVE A FULLY FUNCTIONAL DEVICE IN PLACE OF THEIR CONTAMINATED DEVICE. THESE OPTIONS WERE RELAYED TO THE CUSTOMER VIA EMAIL ON 11/20/23. AS OF THE DATE OF THIS REPORT THE CUSTOMER HAS NOT RESPONDED TO THESE OPTIONS. A FOLLOW-UP WILL BE FILED IF ANY ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Additional Manufacturer Narrative · 0

    FOLLOWING HPC TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THE SOURCE OF THE CONTAMINATION IS LIKELY THE FACILITY WATER SUPPLY, AS SAMPLES TAKEN FROM THE WATER SUPPLY ALSO FAILED HPC TESTING. THE CUSTOMER AGREED TO ONLY USE STERILE WATER UNTIL THEIR WATER FILTRATION SYSTEM IS ADDRESSED. IN ORDER TO REMEDIATE THE DEVICES BACTERIAL CONTAMINATION, THE CUSTOMER SENT THE DEVICE TO CARDIOQUIP FOR REPAIR. THE DEVICE WAS RETURNED TO SPECIFICATION VIA AN INTERNAL WATER PATHWAY REPLACEMENT. FOLLOWING THE REPAIR, THE DEVICE PASSED INSPECTION AND IS FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    LAB RESULTS((B)(6) 2023):(B)(6) - 151 MPN/ML (ABOVE ACCEPTABLE LIMIT). TO REMEDIATE THE DEVICE CONTAMINATION, THE CUSTOMER EITHER PROCEED WITH AN INTERNAL WATER PATH REPLACEMENT PROCEDURE OR A TRADE-IN PROGRAM.

    Description of Event or Problem · 0

    LAB RESULTS (ON (B)(6) 2023): (B)(6) 151 MPN/ML (ABOVE ACCEPTABLE LIMIT). TO REMEDIATE THE DEVICE CONTAMINATION, THE CUSTOMER EITHER PROCEED WITH AN INTERNAL WATER PATH REPLACEMENT PROCEDURE OR A TRADE-IN PROGRAM.

    Description of Event or Problem · 0

    LAB RESULTS ((B)(6) 2023): (B)(6) - 151 MPN/ML (ABOVE ACCEPTABLE LIMIT). TO REMEDIATE THE DEVICE CONTAMINATION, THE CUSTOMER EITHER PROCEED WITH AN INTERNAL WATER PATH REPLACEMENT PROCEDURE OR A TRADE-IN PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825369 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown