BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARLINK SOLUTION SET

    MDR report key: 536858 · Received March 19, 2004

    Report

    Report Number
    6000001-2004-00496
    Event Type
    Other
    Date Received
    March 19, 2004
    Date of Event
    February 1, 2004
    Report Date
    February 19, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    VAGUE, ANECDOTAL WAS REC'D FROM BAXTER-INDICATING INCREASE IN CENTRAL LINE BACTEREMIA. THE ACCOUNT REPORTS GRAM-POSITIVE ORGANISM CULTURES WERE FOUND IN CENTRAL LINES USING THE CLEARLINK VALVE. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SOLUTION SET CLEARLINK SOLUTION SET FPA BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other