BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 18095604 · Received November 8, 2023

    Report

    Report Number
    3007899424-2023-00420
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 16, 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
    IL, 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, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THE CUSTOMER THEN 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.

    Additional Manufacturer Narrative · 0

    A CUSTOMER REQUESTED DEVICE TESTING DUE TO ALLEGED BACTERIAL CONTAMINATION. HPC TESTING WAS PERFORMED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. FOLLOWING TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THE CUSTOMER AGREED TO THAT SERVICE. CURRENTLY CARDIOQUIP IS WAITING TO RECEIVE THE DEVICE IN ORDER TO PERFORM THE SERVICE. FOLLOWING THE INTERNAL WATER PATHWAY REPLACEMENT, THE DEVICE WILL BE RETURNED TO SPECIFICATION. A FOLLOW-UP WILL BE FILED IF ANY ADDITIONAL INFORMATION OR INFORMATION THAT CORRECTS THIS REPORT IS OBTAINED.

    Description of Event or Problem · 0

    BASED ON THESE RESULTS (10161342 -137000 MPN/ML), THIS DEVICE IS ABOVE THE ACCEPTABLE LIMITS FOR WATER QUALITY IN CARDIOQUIP COOLER-HEATER. TO REMEDIATE THE DEVICE CONTAMINATION, THE FACILITY CAN EITHER PERFORM AN INTERNAL WATER PATH REPLACEMENT (IWPR) OR PARTICIPATE IN CARDIOQUIP'S TRADE-IN PROGRAM.

    Description of Event or Problem · 0

    BASED ON THESE RESULTS (10161342 -137000 MPN/ML), THIS DEVICE IS ABOVE THE ACCEPTABLE LIMITS FOR WATER QUALITY IN CARDIOQUIP COOLER-HEATER. TO REMEDIATE THE DEVICE CONTAMINATION, THE FACILITY CAN EITHER PERFORM AN INTERNAL WATER PATH REPLACEMENT (IWPR) OR PARTICIPATE IN CARDIOQUIP'S TRADE-IN PROGRAM.

    Description of Event or Problem · 0

    BASED ON THESE RESULTS (10161342 -137000 MPN/ML), THIS DEVICE IS ABOVE THE ACCEPTABLE LIMITS FOR WATER QUALITY IN CARDIOQUIP COOLER-HEATER. TO REMEDIATE THE DEVICE CONTAMINATION, THE FACILITY CAN EITHER PERFORM AN INTERNAL WATER PATH REPLACEMENT (IWPR) OR PARTICIPATE IN CARDIOQUIP'S TRADE-IN PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582721 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown