BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10027# AVALON ELITE 27F, 31CM

    MDR report key: 4252637 · Received November 5, 2014

    Report

    Report Number
    8010762-2014-01223
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    June 5, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVAL. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    "A FDA MAUDE EVENT REPORT - (B)(4) WAS RECEIVED ON (B)(6) 2014 WHICH REPORTED THAT WHILE MONITORING VV ECHMO, 27FR 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 RE-PRIMING, CIRCUIT WAS NOTED TO BE CRACKED JUST DISTAL TO THE BIFURCATION." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710176 10027# AVALON ELITE 27F, 31CM DWF MAQUET CARDIOPULMONARY AG 10027# AVALON ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention