BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGEN DUAL LUMEN CANNULA, 12 FR

    MDR report key: 358341 · Received October 25, 2001

    Report

    Report Number
    MW1023209
    Event Type
    Injury
    Date Received
    October 25, 2001
    Date of Event
    October 16, 2001
    Report Date
    October 22, 2001
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT BORN WITH LARGE RIGHT DIAFRAGMATIC HERNIA WAS PLACED ON ECUO IN THE MORNING. SURGEON HAD TO SUTURE CANNULA TO PT'S HEAD ON AN ANGLE. ECUO SPECIALIST WENT TO PRESS SUTURED AREA AND NOTICED BLOOD ALL AROUND VENOUS CONNECTION. INITIAL THOUGHT WAS THAT SHE WAS SQUEEZNG TOO HARD. ECUO COORDINATOR WENT TO BLOT AROUND VENOUS CONNECTION AND REALIZED IT HAD SLIPPED OUT OF THE CONNECTION. HELD TOGETHER MANUALLY UNTIL SURGEON COULD RETURN WITH RE-CANNULATE. OPENED TWO MORE PACKAGES OF THE SAME LOT. COULD PULL OUT VENOUS CONNECTION EASILY. CALLED ORIGEN ONLY 45/800 STILL IN STOCK. SENT MAIL MESSAGE TO ECMO CENTERS ALERTING THEM TO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48337 ORIGEN DUAL LUMEN CANNULA, 12 FR * DWF ORIGEN BIOMEDICAL, INC. VV12F 35 BC18155

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention