BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 270591 · Received March 15, 2000

    Report

    Report Number
    270591
    Event Type
    Malfunction
    Date Received
    March 15, 2000
    Date of Event
    November 23, 1999
    Report Date
    December 4, 1999
    Manufacturer
    BAXTER HEALTHCARE RENAL DIV.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAK DETECTOR ALARM AT START OF PT TREATMENT. PINK TINGED FLUID IN DIALYSATE LINE. CHECKED POSITIVE FOR BLOOD WITH MULTISTIX REAGENT STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER CT-190 DIALYZER FJI BAXTER HEALTHCARE RENAL DIV. CT-190 DIALYZER A99C22X

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR