BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10982757 · Received December 10, 2020

    Report

    Report Number
    9611109-2020-00677
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 10, 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)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA FIELD SERVICE REPRESENTATIVE DISPATCHED TO THE CUSTOMER'S FACILITY WAS ABLE TO CONFIRM THE ISSUE. TO SOLVE THE ISSUE THE STIRRER MOTOR AND THE DISTRIBUTION BOARD WERE REPLACED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR MESSAGE ASSOCIATED TO THE STIRRER MOTOR DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453600 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1