BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPH

    MDR report key: 3002731 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06043
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 21, 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 WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PICTURE WAS AVAILABLE, BUT DID NOT SHOW THE DIALYZER OR THE SOURCE OF THE REPORTED LEAK. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BLOOD LEAK FROM THE CONNECTION OF THE DIALYZER AND STREAM STERILIZED BLOODLINE WITH AN ARTERIAL CHAMBER ON THE ARTERIAL SIDE DURING HEMODIALYSIS THERAPY. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT MEDICAL INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105236 XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 11L29B

    Patients

    Seq Age Sex Outcome Treatment
    1 BLOODLINES