BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 20046261 · Received August 23, 2024

    Report

    Report Number
    3007899424-2024-00112
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 22, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    UDI-DI
    00860000846103
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CARDIOQUIP CUSTOMER COMPLETED HPC TESTING ON THEIR DEVICE. FOLLOWING TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDED THAT EITHER, (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. THESE OPTIONS WOULD RETURN THE DEVICE TO SPECIFICATION AND FULL FUNCTIONALITY. ON 08/15/2024 THE CUSTOMER REQUESTED A DEVICE TRADE IN QUOTE. NO NEW INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT. IF THE CUSTOMER PROCEEDS WITH A TRADE IN THEY WILL RECEIVE A BRAND NEW DEVICE WHICH IS FULLY FUNCTIONAL AND WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    A CARDIOQUIP CUSTOMER REQUESTED AN IWPR QUOTE DUE TO WATER SAMPLES THAT WERE COLLECTED AND TESTED BY THE CUSTOMER, RESULTING IN HPC TEST RESULTS OF 507,000 MPN/ML, EXCEEDING THE <100 MPN/ML THRESHOLD FOR CONTAMINATION. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363127 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I) 00860000846103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown