BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPH

    MDR report key: 2925321 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01636
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 2, 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). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF RELEVANT ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A BLOOD LEAK COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A HOSPITAL REPRESENTATIVE CONTACTED BAXTER (B)(4) REGARDING A BLOOD LEAK FROM A XENIUM 210 DIALYZER. IT WAS REPORTED THAT WHEN THE HOME PATIENT (HP) WENT TO CHECK HIS BLOOD PRESSURE AFTER TWO HOURS OF DIALYSIS, HE NOTICED SPECKS OF DRIED BLOOD ON THE FLOOR. THE HP THEN NOTICED A LOT OF BLOOD ON THE SHOWER TRAY AND THAT BLOOD WAS LEAKING FROM THE RED END OF THE DIALYZER, AT THE CONNECTION SITE WHERE THE BLOODLINES SCREW IN. AFTER DISCOVERING THE BLOOD LEAKAGE THE PATIENT TOOK HIMSELF OFF AND DIDN'T WASH HIS BLOOD BACK AS HE THOUGHT IT COULD BE CONTAMINATED IN SOME WAY. THE PATIENT STATED THAT IT IS DIFFICULT TO SCREW THE LINES IN. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31337 XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 12B09B

    Patients

    Seq Age Sex Outcome Treatment
    1 BLOODLINES