BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1062270 · Received June 17, 2008

    Report

    Report Number
    3003464075-2008-00258
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 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 REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT COMPLETING RINSEBACK DUE TO SALINE BAG RUNNING DRY. THE EXACT CAUSE OF THE ARTERIAL AIR ALARM CANNOT BE DETERMINED BUT WAS UNLIKELY RELATED TO THE CARTRIDGE AS IT OCCURRED AT THE END OF TREATMENT. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. 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. AN ARTERIAL AIR ALARM OCCURRED AT THE END OF A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK WAS NOT FULLY COMPLETED AS THE OPERATOR RAN OUT OF SALINE, RESULTING IN AN ESTIMATED BLOOD LOSS OF 25CC. 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 8027703

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other