BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1374735 · Received March 4, 2009

    Report

    Report Number
    3003464075-2009-00107
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 9, 2009
    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 REPORTED BLOOD LOSS IS ATTRIBUTED TO CLOTTING OF THE PATIENT'S CIRCUIT, PREVENTING COMPLETION OF RINSEBACK. FACILITY STAFF ATTRIBUTED THE CLOTTING TO ISSUES WITH THE PATIENT ACCESS, WHICH HAVE SINCE BEEN RESOLVED. THE CYCLER ALARMED APPROPRIATELY IN RESPONSE TO THE CLOTTING. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION 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. AN ARTERIAL PRESSURE ALARM FOLLOWED BY AN ARTERIAL AIR ALARM OCCURRED SHORTLY AFTER STARTING A ROUTINE HEMODIALYSIS TREATMENT. A COMPLETE RINSEBACK COULD NOT BE COMPLETED DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 30CC. 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 8127704

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other