BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA CARDIOPLEGIA

    MDR report key: 7137391 · Received December 19, 2017

    Report

    Report Number
    MW5074124
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 18, 2017
    Report Date
    December 18, 2017
    Manufacturer
    LIVANOVA
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ROACH FOUND IN PRODUCT AND STILL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906985 LIVANOVA CARDIOPLEGIA CARDIOPLEGIA DWF LIVANOVA 1716400136

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other