BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIQUIP MODULAR HEATER COOLER

    MDR report key: 12685978 · Received October 22, 2021

    Report

    Report Number
    3007899424-2021-00032
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 12, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    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 EVENT ALTHOUGH NO PATIENT INFORMATION WAS COMMUNICATED. CARDIOQUIP COULD NOT REPRODUCE THE ISSUES REPORTED BY THE CUSTOMER DURING INVESTIGATION. IT WAS DETERMINED THAT THE DEVICE WAS NOT OPERATED WITH COLD WATER IN THE WATER TANK FOR AN EXTENDED PERIOD LEADING TO AN OVERTEMP ERROR. THE DEVICE WAS INSPECTED AND IS FULLY OPERATIONAL.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE DEVICE RAN NORMALLY AT 37 C, BUT WHEN OPERATED AT 42C IT WENT OVER THE SET POINT TO 43.3 C AFTER A FEW HOURS. THE HOSES WERE CHECKED FOR KINKS OR CLOGS BUT NONE WERE FOUND. IT WAS NOTICED THE MOTOR IMPELLAR/PUMP WAS LOUDER THAN USUAL.

    Description of Event or Problem · 0

    THE DEVICE RAN NORMALLY AT 37 C , BUT WHEN OPERATED AT 42C IT WENT OVER THE SET POINT TO 43.3 C AFTER A FEW HOURS. THE HOSES WERE CHECKED FOR KINKS OR CLOGS BUT NONE WERE FOUND. IT WAS NOTICED THE MOTOR IMPELLAR/PUMP WAS LOUDER THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580633 CARDIQUIP MODULAR HEATER COOLER CARDIOPULMONARY BYPASS COOLER HEATER DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown