BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM 170G SYNTH HF DIALYZER

    MDR report key: 1850573 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03996
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED SEVERAL XENIUM DIALYZERS WITH LEAKS. PER THE INFORMATION PROVIDED, NO INJURY PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM 170G SYNTH HF DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 09F22S

    Patients

    Seq Age Sex Outcome Treatment
    1