BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 18924609 · Received March 18, 2024

    Report

    Report Number
    3007899424-2024-00016
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 9, 2024
    Report Date
    March 18, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    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 SUBMITTED PHOTOS OF TUBING TO EPIDEMIOLOGY. DUE TO THE DISCOLORATION OF THE TUBING, EPIDEMIOLOGY RECOMMENDED THAT THE DEVICE RECEIVE HPC TESTING TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. 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. THE CUSTOMER CHOOSE TO REPERFORM CLEANING AND DISINFECTION AND HPC TESTING. RESULTS AFTER CLEANING AND DISINFECTION WERE WITHIN CARDIOQUIP SPECIFICATIONS FOR WATER QUALITY, AND THE DEVICE WAS RETURNED TO FULL FUNCTIONALITY.

    Description of Event or Problem · 0

    CQ SERVICE WAS NOTIFIED VIA EMAIL THAT THE CUSTOMER TOOK WATER SAMPLES OF THIS DEVICE, AND PRODUCED RESULTS OF 414000 MPN/ML, OVER THE <100 MPN/ML THRESHOLD FOR CONTAMINATION. THIS ISSUE WAS IDENTIFIED ON (B)(6) 2024, NO PATIENT INVOLVEMENT WAS REPORTED. (NQA)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277130 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown