BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOODLINE FOR HEMODIALYSIS

    MDR report key: 2133795 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07836
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    September 30, 2009
    Report Date
    October 9, 2009
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO SAMPLE AVAILABLE FOR EVALUATION. THE ISSUE WAS NOT CONFIRMED BECAUSE THERE WAS NOT ENOUGH INFORMATION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED THAT WHILE USING THE CAPILLARY SYSTEM AND NEW LINES FOR DIALYSIS, THE PATIENT'S BLOOD SYSTEM WAS ALREADY GELLING AS IT ARRIVED IN THE VENOUS LINE. THE FACILITY BEGAN TO USE THESE BAXTER BLOOD LINES ABOUT 10 DAYS AND SINCE THIS TYPE OF EVENT BEGAN. SO FAR 18 SYSTEMS OF ARTERIAL AND VENOUS LINES AND CAPILLARIES HAVE BEEN LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOODLINE FOR HEMODIALYSIS SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK BAXTER HEALTHCARE - CALI SX09EE0

    Patients

    Seq Age Sex Outcome Treatment
    1