BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPM

    MDR report key: 2974304 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04470
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 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 CONFIRMED DURING EVALUATION OF THE RETURNED SAMPLE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED ON THE DIALYZER AND NO OBVIOUS DEFECTS WERE FOUND. A LEAK TEST WAS PERFORMED AND THE DIALYZER LEAKED FROM THE VENOUS HEADER. A WEAK AREA WAS OBSERVED IN HEADER WHERE HEADER IS SOLDERED TO THE DIALYZER. A RETAINED SAMPLE FROM THE SAME LOT WAS VISUALLY AND FUNCTIONALLY TESTED BY (B)(4) WITH NO DAMAGE OR LEAKS NOTED. A MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED BY (B)(4) 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). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. 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. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    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
    78391 XENIUM XPM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 12G02B

    Patients

    Seq Age Sex Outcome Treatment
    1