BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1984105 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01751
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    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). ONE USED TRANSFER SET WAS RECEIVED WITH A CAP ON THE SPIKE, BUT NO CAP ON PATIENT CONNECTOR. THE TRANSFER SET WAS TESTED UNDERWATER WITH A LEAK NOTED FROM A CUT APPROXIMATELY 2 AND 1/4 INCHES FROM THE SLEEVE IN THE CLOSED POSITION. THIS REPORT WAS CONFIRMED FOR A LEAK. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT INFORMATION WAS UNKNOWN. 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.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT A LEAK WAS FOUND FROM THE TUBING OF A TRANSFER SET. THE NURSE REPORTED THE TRANSFER SET HAD BEEN USED BY THE PATIENT FOR (B)(6). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1