BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 8577146 · Received May 3, 2019

    Report

    Report Number
    9611109-2019-00306
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 3, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    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 (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THE FAULT WAS DUE TO THE DAMAGED COMPRESSOR OF THE COOLING SYSTEM. THE DEVICE WAS REMOVED FROM SERVICE. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T TRIGGERED THE FUSES DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370828 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1