BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 18378983 · Received December 21, 2023

    Report

    Report Number
    3007899424-2023-00488
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 13, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Additional Manufacturer Narrative · 0

    FOLLOWING TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS FOR WATER QUALITY, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT OR PARTICIPATE IN CARDIOQUIP'S TRADE IN PROGRAM. THIS WOULD RETURN THE DEVICE TO SPECIFICATION AND FULL FUNCTIONALITY. THESE OPTIONS WERE RELAYED TO THE CUSTOMER VIA EMAIL ON 12/14/23. 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.

    Description of Event or Problem · 0

    LAB RESULTS (ON (B)(6) 2023): (B)(6) 44000 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): 10161927 - 44000 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
    288247 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown