BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1081685 · Received July 24, 2008

    Report

    Report Number
    3003464075-2008-00336
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK. EVALUATION OF THE RETURNED CARTRIDGE FOUND NO PROBLEMS. FACILITY STAFF ATTRIBUTED THE WHITE SUBSTANCE TO CHOLESTEROL BUILDUP. THIS DOES NOT APPEAR TO BE DEVICE RELATED. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS AN ADVERSE EVENT SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. A VENOUS AIR ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. WHILE ATTEMPTING TO TROUBLESHOOT THE ALARM, AN UNKNOWN WHITE SUBSTANCE WAS OBSERVED IN THE VENOUS LINE. TREATMENT WAS ENDED WITHOUT PERFORMING RINSEBACK RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. 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-170 8027713

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other