BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA

    MDR report key: 6519606 · Received April 21, 2017

    Report

    Report Number
    MW5069288
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Report Date
    April 21, 2017
    Manufacturer
    SORIN GROUP/LIVANOVA
    Product Code
    DTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEONATAL ARTERIAL FILTER LEAKING FROM SEAM PRIOR TO INITIATING BYPASS. CRACK IN FILTER WAS FOUND ON BOTTOM CORNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291885 LIVANOVA NEONATAL ARTERIAL FILTER DTM SORIN GROUP/LIVANOVA 075104800 1632800054

    Patients

    Seq Age Sex Outcome Treatment
    1