BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 12798574 · Received November 11, 2021

    Report

    Report Number
    3007899424-2021-00043
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 12, 2021
    Report Date
    July 1, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 NOTIFIED CARDIOQUIP, THAT A PATIENT WAS INVOLVED DURING THE MALFUNCTION ALTHOUGH NO PATIENT INFORMATION WAS COMMUNICATED. CARDIOQUIP'S INVESTIGATION DETERMINED THAT THE HEATER, PUMP, TANK, AND HEATER CHAMBER TO BE NONFUNCTIONAL. FOLLOWING REPLACEMENT, THE DEVICE PASSED INSPECTION, AND IS FULLY OPERATIONAL..

    Additional Manufacturer Narrative · 0

    CARDIOQUIP HAS NOT RECEIVED THE DEVICE FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, CARDIOQUIP WILL FILE SUPPLEMENTARY REPORTS.

    Description of Event or Problem · 0

    CUSTOMER REPORTS DEVICE IS OVERHEATING WHILE IN USE.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THE DEVICE IS OVERHEATING WHILE IN USE. WHEN THE CUSTOMER BIOMED INSPECTED THE DEVICE, THEY FOUND THAT THE UNIT'S COOLING FAN WAS NOT WORKING AS INTENDED AND THAT THE DEVICE OVERHEATED FOR THEM AS WELL SHORTLY AFTER CIRCULATING WATER. THE DEVICE WAS SWAPPED OUT FOR A REPLACEMENT AND THE CASE CONTINUED AS EXPECTED, THE CUSTOMER REPORTS THAT THIS ISSUE DID NOT NEGATIVELY IMPACT PATIENT HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696518 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown