BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27 FR AVALON ELITE DOUBLE LUMEN CANNULA

    MDR report key: 3944691 · Received July 11, 2014

    Report

    Report Number
    MW5037293
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 25, 2014
    Manufacturer
    *
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE MONITORING VV ECHMO, 27 FR AVALON ELITE DOUBLE LUMEN CANNULA WAS BEING USED DURING ECMO. CARDIOHELP AIR DETECTION ALARM TRIGGERED AT THE TIME PT WAS ASLEEP. CIRCUIT CLAMPED AND FLOW STOPPED. WHILE REPRIMING, CIRCUIT WAS NOTED TO BE CRACKED JUST DISTAL TO THE BIFURCATION. DIAGNOSIS OR REASON FOR USE: ACUTE RENAL FAILURE. MFR REPORTED AS NOVOSCI, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406967 27 FR AVALON ELITE DOUBLE LUMEN CANNULA VV ECMO 27 FR AVALON ELITE DOUBLE LUMEN CANNULA DWF * * 70080506

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention