BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD DISP DISCONNECT, UV FLASH

    MDR report key: 1051218 · Received May 23, 2008

    Report

    Report Number
    1423500-2008-00406
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K902526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADD'L PMA/510(K)#'S: K961825, K883239. EVAL SUMMARY: RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF LEAK IN THE DRAIN BAG OF A Y-SET. THIS WAS DUE TO A CUT/SLICE/HOLE. THE ROOT CAUSE WAS UNDETERMINED. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS, AND TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    BAXTER (B) (4) REPORTED LEAKAGE FROM THE DRAIN BAG ON A Y-SET. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD DISP DISCONNECT, UV FLASH Y-SET/78KDJ KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1