BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM 170G SYNTH HF DIALYZER

    MDR report key: 1850590 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-04002
    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 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.

    Description of Event or Problem · 1

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

    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