BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1020379 · Received March 7, 2008

    Report

    Report Number
    3003464075-2008-00102
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 11, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE CARTRIDGE HAD BEEN DISCARDED. THE EXACT CAUSE OF THE FILTER LEAK CANNOT BE CONFIRMED, HOWEVER REVIEW OF COMPLAINT HISTORY SUGGESTS THE REPORTED LEAK WAS MOST LIKELY CAUSED BY EXPOSURE OF THE FILTER TO HIGH PRESSURES OVER AN EXTENDED PERIOD OF TIME POSSIBLY FROM CLOTTING THAT MAY HAVE OCCURRED IN THE ARTERIAL HEADER OF THE FILTER WHICH LED TO A LOSS IN FILTER INTEGRITY AND THE RESULTANT LEAK. THERE WAS NO PT INJURY AS A RESULT OF THIS EVENT. THE USER'S GUIDE INCLUDES THE FOLLOWING WARNING "THE RISK OF CLOTTING INCREASES DURING LONG TREATMENTS, WHEN BLOOD FLOW STOPS, AND WHEN NO ANTICOAGULATION IS USED. FAILURE TO RESPOND TO CLOTTING MAY EXPOSE THE BLOOD CIRCUIT AND FILTER TO SUSTAINED HIGH PRESSURES LEADING TO A POSSIBLE FILTER BLOOD LEAK OR HEMOLYSIS. THE RISK IS HIGHEST IN LONG HEMODIALYSIS TREATMENTS, ESPECIALLY WHEN NO ANTICOAGULATION IS USED. ALWAYS CLOSELY MONITOR FOR CLOTTING THROUGH VISUAL INSPECTION AND PERIODIC FLUSHING OF THE FILTER, AND MONITOR THE FILTER CLOSELY FOR ANY EVIDENCE OF A LEAK." THE DEVICE LABELING IS APPROPRIATE FOR THE SAFE AND EFFECTIVE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    PT INFO WAS REQUESTED BUT NOT PROVIDED BY THE REPORTER. IT WAS REPORTED THAT AN EXTERNAL FILTER BLOOD LEAK OCCURRED DURING AN EXTENDED CVVH DIALYSIS TREATMENT. THE AMOUNT OF BLOOD LOST THROUGH THE LEAK WAS ESTIMATED AT APPROX 100CC BEFORE TREATMENT WAS DISCONTINUED. THE PT WAS GIVEN TWO UNITS OF RBC AND TWO UNITS OF PLATELETS. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 7127802

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other