BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN

    MDR report key: 1051216 · Received May 23, 2008

    Report

    Report Number
    1423500-2008-00404
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF LEAKAGE FROM THE JUNCTION BETWEEN THE SPIKE PORT OF A YUME-SET ON A TRANSFER SET. THIS WAS DUE TO A BROKEN SPIKE. THE ROOT CAUSE OF THE BROKEN SPIKE WAS UNDETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MFG AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    BAXTER REPORTED A LEAKAGE FROM THE JUNCTION BETWEEN THE SPIKE PORT OF A YUME-SET ON A TRANSFER SET. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN TRANSFER SET/78KDJ KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1