BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1103145 · Received August 8, 2008

    Report

    Report Number
    3003464075-2008-00364
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 12, 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 PERFORMING RINSEBACK IN A TIMELY MANNER. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. THE DISPOSABLE CARTRIDGE WAS NOT RETURNED FOR EVAL. THE EXACT CAUSE OF THE SYSTEM ALARM CANNOT BE DETERMINED, BUT IS UNLIKELY CARTRIDGE RELATED SINCE THE TREATMENT WAS ALMOST COMPLETED. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING SYSTEM ALARMS. 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 AND ADD'L TRAINING PROVIDED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L 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 SYSTEM ALARM OCCURRED WITH 30 MINUTES REMAINING IN A ROUTINE HEMODIALYSIS TREATMENT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other