BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1943310 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07496
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    July 13, 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). TWO USED SETS WERE RECEIVED WITH CAP ON DARK BLUE CONNECTOR AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO THE REPORT OF DIFFICULT TO OPEN AND CLOSE. THE SLEEVES WERE OPENED AND CLOSED SEVERAL TIMES WITHOUT DIFFICULTY. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY. SETS WERE THEN TESTED UNDERWATER AT 8 POUNDS PER SQUARE INCH WITH LEAKING NOTED. SETS WERE VISUALLY INSPECTED AND NOTED THAT BOTH OF THE OCCLUDER FEET WERE BROKEN ON ONE SET. DURING VISUAL INSPECTION, IT WAS NOTED THAT THERE WAS NO WHITISH SPOT ON THE OCCLUDER LEG THAT IS INDICATING A POSSIBLE OVER-TORQUING. THE COMPLAINT WAS CONFIRMED IN THE LAB FOR CRACK. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THE TRANSFER SET WAS DIFFICULT TO OPEN AND CLOSE, AND THAT THE PATIENT HAD TO USE EXCESSIVE POWER TO OPEN AND CLOSE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1