BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1934895 · Received December 21, 2010

    Report

    Report Number
    1423500-2010-07129
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 29, 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). THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE USED SET WAS RECEIVED WITH NO CAP ON SPIKE AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO CONNECTION ISSUE. DURING VISUAL INSPECTION, THE PATIENT CONNECTOR CONTAINED WHAT APPEARED TO BE A MARK CAUSED FROM A TORQUING THE DEVICE. NO MANUFACTURING ABNORMALITIES WERE NOTED. THE SET WAS TESTED UNDERWATER AT 8 PSI WITH NO LEAK NOTED. THE COMPLAINT COULD NEITHER BE CONFIRMED IN THE LAB NOR DUPLICATED UNDER LAB CONDITIONS WITH THE RETURNED SAMPLE. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT THE SET COULD NOT BE CONNECTED BY CLEAN FLASH. THE SPIKE WAS NOT CONNECTED WITH ANYTHING WHEN THE LID OF THE CLEAN FLASH WAS OPENED. 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