BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10903702 · Received November 25, 2020

    Report

    Report Number
    9611109-2020-00657
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    September 1, 2020
    Report Date
    November 23, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 PATIENT BRIDGE WAS REPLACED AND THE ISSUE SOLVED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CASE CAN BE TRACED BACK TO A CORRODED AND/OR DAMAGED BEARINGS OR ABRADED BUSHINGS, PROBABLY DUE TO ENVIRONMENTAL CONDITIONS WHICH THE PUMPS WORKED IN, 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 TO HAVE A DEFECTIVE PATIENT BRIDGE DURING A SERVICE ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370285 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-82

    Patients

    Seq Age Sex Outcome Treatment
    1