BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION KIT

    MDR report key: 1013228 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06163
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKAGE BELOW THE VAMP SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION KIT BLOOD SAMPLING KIT DQO EDWARDS LIFESCIENCES CCUNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN