BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1251701 · Received December 2, 2008

    Report

    Report Number
    3003464075-2008-00621
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 3, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY. FACILITY STAFF ATTRIBUTED CLOTTING OF THE EXTRACORPOREAL BLOOD CIRCUIT AND THE BLOOD LOSS TO THE OPERATOR STOPPING THE PUMP DURING TREATMENT. THE USER'S GUIDE STATES THE RISK OF BLOOD CLOTTING IN THE CARTRIDGE AND FILTER INCREASES DURING LONG TREATMENTS, WHEN BLOOD FLOW STOPS, AND WHEN NO ANTICOAGULATION IS USED. GIVE THE MONITOR ANTICOAGULANTS AS YOUR CENTER INSTRUCTS. 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 PRESSURE HIGH ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT, WHICH COULD NOT BE RESOLVED BY THE OPERATOR. RINSEBACK WAS NOT PERFORMED DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PT'S STANDARD HEPARIN DOSE WAS INCREASED. NO OTHER 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 8097702

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other