BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 15366444 · Received September 6, 2022

    Report

    Report Number
    3007899424-2022-00101
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    November 9, 2021
    Report Date
    June 7, 2023
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS REPORTING THE FOLLOWING COMPLAINT AFTER A VOLUNTARY REVIEW OF ALL COMPLAINTS (REPORTABLE OR NOT) SINCE 2016. THIS REPORT IS BEING FILED NOW, AFTER BEING SCRUTINIZED UNDER A NEWLY REVISED RISK MATRIX, RECENTLY ADOPTED AFTER INSPECTION. THE CUSTOMER REPORTS THAT DEVICES AT THE FACILITY HAVE TESTED POSITIVE FOR NTM. NO DETERMINATION WAS ABLE TO BE MADE ABOUT WHETHER THE DEVICE CAUSED AN ADVERSE EVENT AS CARDIOQUIP DOES NOT HAVE ACCESS TO THE DEVICE TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    CARDIOQUIP SERVICE WAS NOTIFIED BY THE CUSTOMER THAT THE DEVICE HAD TESTED POSITIVE FOR NTM, VIA INTERNAL TESTING AT THEIR FACILITY. FOLLOWING A DELAY DUE TO TEMPORARILY CEASED COMMUNICATION, A CARDIOQUIP TECHNICIAN GAINED ACCESS TO THE DEVICE DURING PREVENTATIVE MAINTENANCE. DUE TO THE DISCOLORATION SEEN IN THE TUBING, THE TECHNICIAN SUBMITTED PICTURES TO CARDIOQUIP EPIDEMIOLOGY AND EPIDEMIOLOGY RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THE DEVICE WAS THEN SHIPPED TO CARDIOQUIP FOR REPAIR AND FOLLOWING THE INTERNAL WATER PATHWAY REPLACEMENT, AN INSPECTION WAS PERFORMED AND THE DEVICE IS FULLY FUNCTIONAL AND BACK WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    CUSTOMER REPORTS DEVICE TESTED POSITIVE FOR NTM.

    Description of Event or Problem · 0

    CUSTOMER AND CARDIOQUIP TECHNICIAN BOTH OBSERVE BACTERIAL CONTAMINATION WITHIN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182596 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown