BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 19934508 · Received August 7, 2024

    Report

    Report Number
    3007899424-2024-00104
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 7, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    UDI-DI
    00860000846103
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CARDIOQUIP TECHNICIAN SUBMITTED PHOTOS OF TUBING TO EPIDEMIOLOGY FOR INVESTIGATION DURING AN ON-SITE INSPECTION. 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 CHOSE 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 A WATER SAMPLE SUBMITTED BY THE CUSTOMER FOR THIS DEVICE FAILED WITH A RESULT OF 770 MPN/ML, EXCEEDING THE 100 MPN/ML LIMIT. THIS ISSUE WAS IDENTIFIED ON 07/09/2024, NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398563 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I) 00860000846103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown