BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1230499 · Received June 26, 2008

    Report

    Report Number
    3003464075-2008-00279
    Event Type
    Injury
    Date Received
    June 26, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 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

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT RESPONDING TO THE ALARM APPROPRIATELY IN A TIMELY MANNER. THE OPERATOR STATED THAT THERE WAS NO VISIBLE BLOOD IN THE WASTE LINE. REVIEW OF THE TREATMENT LOG FILE INDICATES THAT THE ALARM WAS PRECEDED BY MULTIPLE THERAPY FLUID AIR ALARMS. THE BLOOD LEAK ALARM WAS MOST LIKELY CAUSED BY AIR IN THE EFFLUENT WHICH IS LISTED AS A PROBABLE CAUSE FOR THE ALARM IN THE USER'S GUIDE. OCCASIONAL ALARMS DURING DIALYSIS ARE EXPECTED AND SHOULD NOT RESULT IN A BLOOD LOSS IF DEVICE LABELING IS FOLLOWED. 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 ADDITIONAL INFORMATION WILL BE PROVIDED. SEE SCANNED PAGE.

    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 BLOOD LEAK ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THERE WAS NO VISIBLE BLOOD IN THE DRAIN LINE. RINSEBACK WAS NOT COMPLETED DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other