BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN

    MDR report key: 1904951 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05974
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED TRANSFER SET WAS RECEIVED WITH NO CAP ON THE SPIKE AND NO CAP ON THE PATIENT CONNECTOR IN REFERENCE TO THE REPORT OF A LEAK. THE TRANSFER SET WAS TESTED UNDERWATER AND A LEAK WAS NOTED FROM A CUT APPROXIMATELY 1 AND 5/8 OF AN INCH FROM THE SLEEVE IN THE CLOSED POSITION. THE COMPLAINT WAS CONFIRMED IN THE LAB FOR LEAK. A BATCH REVIEW WAS NOT PERFORMED DUE TO AN UNKNOWN LOT NUMBER. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) A LEAKING TRANSFER SET. THE CUSTOMER STATED THE LEAKAGE WAS COMING FROM THE TUBING. THE TRANSFER SET HAD BEEN IN USE FOR 3 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1