BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10875826 · Received November 20, 2020

    Report

    Report Number
    9611109-2020-00644
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 16, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). LIVANOVA FIELD SERVICE TECHNICIAN DISPATCHED TO THE FACILITY CONFIRMED THE ISSUE AND TRACED IT BACK TO A COMPRESSOR DAMAGE. THE UNIT WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED A REPORT THAT ON A HEATER COOLER 3T CIRCUIT BREAKER TRIGGERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344709 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1