BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPM

    MDR report key: 2970013 · Received February 20, 2013

    Report

    Report Number
    1416980-2013-04249
    Event Type
    Malfunction
    Date Received
    February 20, 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 COMPLAINT 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 CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BLOOD LEAK DURING 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. THE NURSE INFORMED THAT THE ISSUE WAS OBSERVED DURING THE DIALYZERS FIRST USE, AND THE DIALYZERS WERE NOT REUSED. THE NURSE INFORMED THAT THE DIALYZER PASSED THE 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
    73171 XENIUM XPM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 11K14B

    Patients

    Seq Age Sex Outcome Treatment
    1