BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1960631 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00580
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED TRANSFER SET WAS RECEIVED WITH CAP ON SPIKE AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO LEAK. A LAB TITANIUM ADAPTER WAS FUNCTIONALLY HAND TIGHTENED WITHOUT DIFFICULTY. THE TRANSFER SET WAS TESTED UNDERWATER WITH LEAK NOTED FROM CUT APPROXIMATELY 1 5/8 FROM SLEEVE IN CLOSED POSITION. THIS REPORT WAS CONFIRMED FOR A LEAK. A BATCH REVIEW WAS NOT PERFORMED AS 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 SAMPLE HAS BEEN RECEIVED AND IS CURRENTLY BEING EVALUATD BY BAXTER. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS, OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT A LEAK WAS NOTED FROM THE TUBING OF THE TRANSFER SET. THE CUSTOMER REPORTED THAT THE TRANSFER SET HAD BEEN USED FOR 30 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    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