BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 11336863 · Received February 17, 2021

    Report

    Report Number
    9611109-2021-00080
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 16, 2021
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE PROBLEM WAS TRACED BACK TO A DEFECTIVE COMPRESSOR. THE CUSTOMER DECIDED TO SCRAP THE MACHINE DUE TO ITS OLD AGE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T WAS NOT COOLING. THE ISSUE WAS IDENTIFIED DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235802 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1