BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM

    MDR report key: 2073419 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05249
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 28, 2011
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED, THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT THE DIALYZER RUPTURED DURING ITS FIRST USE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 10428PX

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE