BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DLP

    MDR report key: 1328154 · Received February 20, 2009

    Report

    Report Number
    1328154
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 20, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO COMMENCE BYPASS WITH SINGLE SVC CANNULA. THERE WAS NO RETURN AFTER THREE ATTEMPTS TO REPOSITION THE CANNULA PLACEMENT. THE CANNULA WAS CHANGED OUT AND BYPASS WAS INITIATED UNEVENTFULLY.====================== MANUFACTURER RESPONSE FOR CANNULA, VENOUS, CARDIOPULMONARY BYPASS, DLP======================A REPRESENTATIVE FROM THE CANNULA MFR WAS NOTIFIED, CAME TO THE HOSPITAL AND REMOVED ALL CANNULA WITH THE SAME LOT NUMBER FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP CANNULA, VENOUS, CARDIOPULMONARY BYPASS DWF MEDTRONIC PERFUSION SYSTEMS * 2008111016

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO