BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2781397 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02074
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS COMPLAINT FOR A LEAK FROM A MINICAP TRANSFER SET WAS CONFIRMED DURING THE SAMPLE EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH BROKEN OCCLUDER FEET, IN CAVITY 2 NOTED. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED WITH BROKEN OCCLUDER FEET NOTED. CLEAR-PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE SAMPLE EVALUATION WAS COMPLETED, THE PROBLEM CONFIRMED, BUT THE INVESTIGATION IS STILL NOT COMPLETED. THE LOT NUMBER WAS NOT KNOWN, THEREFORE NO BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WAS CONFIRMED DURING THE SAMPLE EVALUATION; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A MINICAP TRANSFER SET. THE REPORTER STATED THAT FLUID HAD LEAKED OUT THE END OF THE TRANSFER SET, EVEN THOUGH HIS SET WAS CLOSED. A LINE CHANGE WAS PERFORMED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY WAS INDICATED WITH THIS REPORT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR