BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPM

    MDR report key: 2962857 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03896
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 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. HOWEVER, A RETAINED SAMPLE FROM THE SAME LOT WAS VISUALLY AND FUNCTIONALLY TESTED BY NIPRO WITH NO DAMAGE OR LEAKS NOTED. THE REPORTED CONDITION WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED BY NIPRO WITH NO ISSUES OR ABNORMALITIES NOTED DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). 9 THE ACTUAL SAMPLE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE HAS BEEN REPORTED TO BE AVAILABLE AND REQUESTED FOR EVALUATION. THE COMPANION SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. 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

    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 50ML. 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
    64450 XENIUM XPM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 12G19B

    Patients

    Seq Age Sex Outcome Treatment
    1