BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 8474287 · Received April 2, 2019

    Report

    Report Number
    9611109-2019-00220
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 5, 2019
    Report Date
    April 2, 2019
    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, BUT IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K052601). LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). HE WAS ABLE TO CONFIRM THE REPORTED ISSUE AND TRACED THE FAILURE TO LEAKING INTERNAL COMPONENTS. THE PARTS WERE REPLACED AND THE DEVICE RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE.

    Description of Event or Problem · 1

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A WATER LEAK FROM A HEATER-COOLER SYSTEM 3T DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267566 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1