BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10738904 · Received October 27, 2020

    Report

    Report Number
    9611109-2020-00598
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 26, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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)(6) MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). THE ROOT CAUSE OF THE REPORTED LEAK WAS CAUSED BY AN ASSEMBLY ERROR. THE YELLOW PLUG ON THE VALVE BLOCK OF THE CARDIOPLEGIA BRIDGE WAS MISSING.

    Description of Event or Problem · 1

    LIVANOVA (B)(6) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T WAS LEAKING WATER DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203476 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1