BEUDAMED
    FDA Adverse Event Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1200467 · Received October 2, 2008

    Report

    Report Number
    1423500-2008-00851
    Date Received
    October 2, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF A TRANSFER SET'S WHITE AND BLUE PARTS PEELING AND NOT CLICKING. BROKEN OCCLUDER FEET WERE ALSO FOUND DURING EVALUATION. THE ROOT CAUSE IS LIKELY THE USE OF ENVIRONMENTAL STRESS CRACKING AGENTS (I.E., CHEMICAL SOLUTIONS IN CONTACT WITH THE PART UNDER AN APPLIED STRESS). RENAL QUALITY ENGINEERING, PLANT AND MANUFACTURING, AND QUALITY PERSONNEL WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS, AND TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED TO BAXTER THAT A CUSTOMER COMPLAINED ABOUT A TRANSFER SET'S WHITE AND BLUE PLASTIC PEELING OFF, AND DOESN'T CLICK ANYMORE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP 78KDJ KDJ BAXTER HEALTHCARE H07K14044

    Patients

    Seq Age Sex Outcome Treatment
    1