BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPH

    MDR report key: 2973781 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04428
    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
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A SAMPLE EVALUATION WAS PERFORMED. A VISUAL INSPECTION WAS PERFORMED AND NO OBVIOUS DEFECTS WERE FOUND. A LEAK TEST WAS PERFORMED AND THERE WAS NO LEAK NOTICED AT THE CONNECTION POINTS.

    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. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    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. 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 AT THE ARTERIAL CONNECTION ON A STREAM STERILIZED BLOODLINE WITH ARTERIAL CHAMBER AND THE DIALYZER. THE PATIENT WAS ABOUT 2 HOURS INTO THE THERAPY SESSION AND THERE HAD BEEN NO LEAK ALL ALONG AS THE PATIENT HAD BEEN CHECKING EVERY 10/15 MINUTES. THE ESTIMATED BLOOD LOSS FOR THE PATIENT WAS 10-20ML. 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
    79102 XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 12H27B

    Patients

    Seq Age Sex Outcome Treatment
    1 BLOODLINES