BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10868334 · Received November 19, 2020

    Report

    Report Number
    9611109-2020-00641
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 16, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). THE TECHNICIAN IN CHARGE REPLACED THE PATIENT PUMP AND SOLVED THE PROBLEM. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE MOST LIKELY ROOT CAUSE IS A BEARING DAMAGE DUE TO CORROSION FORMATION TRACEABLE TO ENVIRONMENTAL CONDITIONS THE PUMP WORKED IN SUCH AS CONDENSATION CAUSED BY WATER INFILTRATION OR HIGH TEMPERATURES AND HIGH LEVELS OF HUMIDITY.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T WAS FOUND WITH A STUCK PATIENT PUMP DURING SERVICE ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332656 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1