BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 11064962 · Received December 23, 2020

    Report

    Report Number
    9611109-2020-00712
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 22, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE TECHNICIAN WAS DISPATCHED TO THE CUSTOMER FACILITY. THE ERROR CODE WAS NOT CONFIRMED. HOWEVER, METAL SHAVINGS WERE FOUND INSIDE THE UNIT, POSSIBLY CAUSED BY A SCREW TOUCHING THE STIRRER MOTOR. IN ORDER TO SOLVE THE ISSUE, THE DISTRIBUTION BOARD AND THE COMPLETE PATIENT BRIDGE WERE REPLACED. THE UNIT WAS TESTED AND PUT BACK IN SERVICE IN ITS EXPECTED FUNCTION. THE REPORTED ERROR WAS MOST LIKELY CAUSED BY THE SCREW TOUCHING THE STIRRER MOTOR COMPROMISING ITS CORRECT ROTATION. BASED ON THE INFORMATION AVAILABLE, IT CANNOT BE RULED OUT THAT AN INCORRECT ASSEMBLY DURING PREVIOUS SERVICE ACTIVITY ON THE DEVICE MAY HAVE CONTRIBUTED TO THIS FAULT.

    Description of Event or Problem · 1

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR MESSAGE ASSOCIATED TO THE STIRRER MOTOR DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532272 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1