BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUARIUS (REGULAR)

    MDR report key: 1220820 · Received October 31, 2008

    Report

    Report Number
    6000002-2008-09115
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    EDWARD LIFESCIENCES
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, IF YOU HAVE CHOSEN "NO ANTICOAGULATION" IT IS POSSIBLE TO PROGRAM HEPARIN IN PROGRAMMING. IT SHOULD NOT BE POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUARIUS (REGULAR) ACUTE BLOOD PURIFICATION MACHINE FII EDWARD LIFESCIENCES GEF09600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK