BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2097159 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05132
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    July 13, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS BEING SUBMITTED AS PART OF RETROSPECTIVE SUMMARY REPORT (B)(4). THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED ON THIS MDR ARE 965 (SEE ATTACHMENT TITLED "KDJ REPORTABLE MALFUNCTIONS"). THESE REPORTS ARE BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING-LETTER (B)(4). RECEIVED TWO USED SETS WITH CAP ON DARK BLUE CONNECTOR ATTACHED AND NO CAP ON PT CONNECTOR IN REFERENCE TO THE REPORTED PROBLEM OF CRACKS. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY AND PRESSURE TESTED UNDERWATER WITH NO LEAK NOTED. DURING VISUAL INSPECTION, CHIPPING/FLAKING AND CRACKS OF THE LIGHT BLUE MAIN BODY AND CAP WERE NOTED. THE COMPLAINT WAS CONFIRMED IN THE LAB FOR CRACK.

    Description of Event or Problem · 1

    AFTER 45 DAYS OF USE, CRACKS WERE NOTED ON THE TWIST SWITCH. THERE WAS NO DISINFECTANT USE ON THE SET BY PT OR DOCTOR. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI