BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM

    MDR report key: 3760137 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12719
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 26, 2014
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER 12B02P WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. THE EVALUATION FOUND NONCONFORMING PRODUCT DESCRIBED AS A FIBER BREAKAGE, WHICH VERIFIED THE REPORTED ISSUE OF A BLOOD LEAK. HOWEVER, A CAUSE OF THE LEAKING DIALYZER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED BY THE NAKED EYE AND NO OBVIOUS DEFECTS WERE FOUND. THE DIALYZER WAS PRIMED WITH WATER AND THEN DRAINED OUT. FUNCTIONAL TESTING WAS PERFORMED WITH AN UNDERWATER FIBER INTENSITY TEST. THERE WERE BUBBLES COMING OUT OF THE DIALYSATE PORT AT THE ARTERIAL END. THIS IS LEAKAGE OF BROKEN FIBERS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAK OCCURRED IN A DIALYZER WHILE IN USE ON A PATIENT (PT) FOR HEMODIALYSIS TREATMENT IN A DIALYSIS CENTER. ABOUT TWO MINUTES INTO THE TREATMENT, THE STAFF NOTICED A BLOOD LEAK AT THE RED END OF THE DIALYZER. THE LEAK WAS FURTHER DESCRIBED AS A SMALL LEAK NEAR THE RED CONNECTOR WHERE THE ARTERIAL LINE GOES INTO THE DIALYZER. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236986 XENIUM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION USD 12B02P

    Patients

    Seq Age Sex Outcome Treatment
    1