BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM LF

    MDR report key: 3021877 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07310
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 13, 2013
    Report Date
    March 1, 2013
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED FOR LEAK. A VISUAL INSPECTION WAS PERFORMED AND NO OBVIOUS DEFECTS WERE FOUND. A RETAINED SAMPLE FROM THE SAME LOT WAS VISUALLY AND FUNCTIONALLY TESTED BY NIPRO WITH NO DAMAGE OR LEAKS NOTED. A MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED BY NIPRO WITH NO ISSUES OR ABNORMALITIES NOTED DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED DIALYZER BY BAXTER PERSONNEL, IT WAS NOTICED THAT A SLOW LEAK WAS COMING FROM THE AREA WHERE THE ARTERIAL HEADER CAP WAS SCREWED ONTO THE DIALYZER. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124669 XENIUM LF DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 11G04PX

    Patients

    Seq Age Sex Outcome Treatment
    1