BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1052806 · Received May 27, 2008

    Report

    Report Number
    3003464075-2008-00220
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK. NO PROBLEM WAS FOUND UPON EVAL OF THE RETURNED CARTRIDGE. BASED ON THE LOG FILE ANALYSIS AND THE CARTRIDGE INSPECTION, THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L 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. PINK TINGED EFFLUENT WAS NOTED DURING A ROUTINE HEMODIALYSIS TREATMENT, WHICH TESTED POSITIVE FOR BLOOD. RINSEBACK WAS NOT COMPLETED RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. PT HAD NO SYMPTOMS AND 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 8017706

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other