BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPH

    MDR report key: 2091902 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06098
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 29, 2011
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    PMA / PMN Number
    K083778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT COULD NOT BE CONFIRMED. THE ACTUAL SAMPLE WAS NOT RETURNED FOR TESTING. A REVIEW OF THE MANUFACTURING, PROCESS INSPECTION AND RELEASE INSPECTION RECORDS WAS PERFORMED AND NO DEFECTS WERE NOTED. IN ADDITION, TESTING OF THE RETAINED SAMPLES BY NIPRO WAS PERFORMED. NO ISSUES WERE FOUND. NO OTHER ABNORMALITIES WERE IDENTIFIED DURING THE EVALUATION OF THE RETAINED SAMPLE. 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

    A NURSE REPORTED TO BAXTER THAT A PATIENT SHOWED PRURITIC REACTIONS AFTER THE THERAPY AND HE BELIEVES THAT THE PROBLEM IS DUE TO THE FIBERS. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 10F24B

    Patients

    Seq Age Sex Outcome Treatment
    1