BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1230498 · Received June 11, 2008

    Report

    Report Number
    3003464075-2008-00246
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 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. FACILITY STAFF ATTRIBUTED THE AIR ALARM TO USER ERROR AS THE OPERATOR MOST LIKELY DID NOT PRESS STOP AT THE END OF TREATMENT PRIOR TO RECONFIGURING CARTRIDGE FOR RINSEBACK WHICH ALLOWED AIR TO ENTER THE CIRCUIT. THE CYCLER ALARMED APPROPRIATELY. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF PROVIDED ADDITIONAL TRAINING REGARDING END OF TREATMENT PROCEDURES. 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 AIR ALARM OCCURRED AT THE END OF A ROUTINE HEMODIALYSIS TREATMENT WITH AIR VISABLE IN THE TUBING AND FILTER. RINSEBACK WAS NOT PERFORMED RESULTING IN AN ESTIMATED BLOOD LOSS OF 120CC. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other