BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1992292 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02018
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 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 SET WAS RECEIVED WITH NO CAP ON SPIKE CONNECTOR AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO CONNECTION ISSUE. FUNCTIONALLY HAND TIGHTENED A (B)(4) LAB TITANIUM ADAPTER WITHOUT DIFFICULTY. THE SET WAS TESTED UNDERWATER WITH NO LEAK NOTED. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS NOT KNOWN. BASED ON THE INFORMATION GATHERED DURING 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. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT WHEN THE PATIENT WAS CONNECTING A TRANSFER SET TO A TWIN BAG USING THE CLEAN FLASH THERE WAS A CONNECTION ISSUE. WHEN THE LID WAS LIFTED THE SPIKE WAS NOT CONNECTED TO ANYTHING. THE PATIENT WAS INVOLVED, BUT THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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