BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1810485 · Received August 20, 2010

    Report

    Report Number
    1423500-2010-02769
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB THAT THE PATIENT ADAPTER WAS SEPARATED FROM THE SILICONE TUBING. NO ROOT CAUSE COULD BE DETERMINED AND A BATCH REVIEW OF THIS SPECIFIC MANUFACTURED LOT WAS CONFIRMED NEGATIVE FOR ANY PROBLEMS. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS AVAILABLE AND REQUESTED.

    Description of Event or Problem · 1

    AFTER USE FOR 30 DAYS, THE TUBING OF THE TRANSFER SET SEPARATED FROM THE PLASTIC PATIENT CONNECTOR OF THE TRANSFER SET. THERE WAS NO DISINFECTANT USE ON THE SET BY THE PATIENT OR DOCTOR. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H09G20046

    Patients

    Seq Age Sex Outcome Treatment
    1