BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM LF

    MDR report key: 2974815 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04507
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CONDITION WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE NO EVALUATION COULD BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED BY NIPRO AND CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. NIPRO ALSO EVALUATED A RETAINED SAMPLE, WHICH FOUND NO ISSUES FOUND. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BLOOD LEAK, DURING USE OF A XENIUM DIALYZER FOR HEMODIALYSIS THERAPY. THE LEAK WAS OBSERVED ON THE SEALING OF THE VENOUS CAP. THE ESTIMATED BLOOD LOSS FOR THE PATIENT WAS 100ML. THE TREATMENT WAS RESUMED WITH A NEW DIALYZER, FROM A DIFFERENT BATCH. THIS OCCURRENCE WAS OBSERVED DURING THE DIALYZER'S FIRST USE, AND THE DIALYZER WAS NOT REUSED. THE DIALYZER PASSED A LEAK TEST PRIOR TO PATIENT USE. 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
    78374 XENIUM LF DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 11F16PX

    Patients

    Seq Age Sex Outcome Treatment
    1