BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAMP FLEX KIT

    MDR report key: 1111987 · Received August 12, 2008

    Report

    Report Number
    6000002-2008-08399
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 25, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    CLASS 1 EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVAL.

    Description of Event or Problem · 1

    LEAKAGE WAS OBSERVED FROM THE CONNECTION BETWEEN THE Z-SITE OF VAMP PLUS AND THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAMP FLEX KIT VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION KIT DRS EDWARDS LIFESCIENCES 600380081 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK