BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 2032079 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03764
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    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). THIS COMPLAINT WAS CONFIRMED BY EVALUATION AS A DAMAGED PORT. THIS DAMAGE RESULTED FROM AN ATTEMPTED CLEAN FLASH CYCLE, DUE TO USE/MIS-USE CONDITIONS. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS AVAILABLE FOR EVALUATION. A 510 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 NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CRACK OCCURRED IN THE PORT OF THE Y-SET WHEN THE PATIENT TRIED TO CONNECT THE TRANSFER SET TO THE Y-SET BY CLEAN FLASH. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD DISCONNECT Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1