BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1911231 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06395
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR CRACK/BROKEN OCCLUDER FEET. THE SLEEVE OF THE USED SET WAS OPENED/CLOSED SEVERAL TIMES WITHOUT DIFFICULTY. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY. SET WAS THEN TESTED UNDERWATER AT 8 PSI WITH LEAK NOTED. DURING VISUAL INSPECTION, IT WAS NOTED THAT THERE WAS NO WHITISH SPOT ON THE OCCLUDER LEG, THE PLANT EVALUATION CITED NO VISIBLE SIGNS OF OVER-TORQUING. THE ROOT CAUSE OF THIS PROBLEM IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT CRACKS WERE NOTED ON THE TWIST SWITCH OF THE TRANSFER SET AFTER (B)(6) OF USE. THERE WAS NO DISINFECTANT USED ON THE SET BY 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 H09H25076

    Patients

    Seq Age Sex Outcome Treatment
    1