BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECMO DOUBLE LUMEN VV CANNULA

    MDR report key: 6321596 · Received February 10, 2017

    Report

    Report Number
    6321596
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    November 23, 2016
    Report Date
    February 2, 2017
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON REVIEW OF THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULAS, IT WAS DISCOVERED BY STAFF THAT THESE CANNULAS HAVE A KNOWN PROBLEM WITH LACK OF BARIUM IMPREGNATION, MAKING THE CANNULA NOT VISIBLE ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107020 ECMO DOUBLE LUMEN VV CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF ORIGEN BIOMEDICAL, INC. VV28F N18487

    Patients

    Seq Age Sex Outcome Treatment
    1