BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM LF

    MDR report key: 2961346 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03751
    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). 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.

    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. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 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
    65283 XENIUM LF DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 11F13PX

    Patients

    Seq Age Sex Outcome Treatment
    1