BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1014001 · Received March 13, 2008

    Report

    Report Number
    3003464075-2008-00113
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CARTRIDGE CONFIRMED A LEAK OCCURRED IN THE ARTERIAL CAP ON THE FILTER. THE CRACK NOTED AT THE CAP WAS MOST LIKELY CAUSED BY STRESS OR FATIGUE. REVIEW OF DEVICE HISTORY RECORDS REVEALED THAT THE LOT OF CAP COMPONENTS MET ALL SPECIFICATION REQUIREMENTS. MECHANICAL STRESS TESTING PERFORMED DURING THE MANUFACTURING PROCESS ALSO PASSED ALL ACCEPTANCE CRITERIA. THERE IS NO EVIDENCE TO SUGGEST THAT A MANUFACTURING DEFECT OCCURRED. THE CAUSE OF THE FILTER CRACK APPEARS TO BE DUE TO A COMPONENT FAILURE, MOST LIKELY CAUSED BY EXPOSURE OF THE FILTER TO PRESSURES OVER AN EXTENDED PERIOD OF TIME, WHICH LED TO A LOSS IN FILTER INTEGRITY AND THE RESULTANT LEAK. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT. THE USER'S GUIDE CONTAINS 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 BLOOD LEAK OR HEMOLYSIS. THE RISK IS HIGHEST IN LONG HEMODIALYSIS TREATMENTS, ESPECIALLY 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. 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

    PATIENT GENDER, AGE AND WEIGHT, WAS 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 LOSS FROM THE LEAK WAS ESTIMATED TO BE 60CC. TREATMENT WAS DISCONTINUED. 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 7127801

    Patients

    Seq Age Sex Outcome Treatment
    1