BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1387838 · Received March 24, 2009

    Report

    Report Number
    3003464075-2009-00137
    Event Type
    Malfunction
    Date Received
    March 24, 2009
    Date of Event
    February 25, 2009
    Report Date
    February 25, 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

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT COMPLETING RINSEBACK IN A TIMELY MANNER FOLLOWING AN UNRECOVERABLE ALARM. THE CYCLER ALARMED APPROPRIATELY TO THE LACK OF DIALYSATE. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE OF THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAVE BEEN NOTIFIED. 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. A BALANCE CHAMBER PRESSURE ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT WHEN THE DIALYSATE FLUID RAN OUT. PARTIAL RINSEBACK WAS PERFORMED, RESULTING IN A ESTIMATED BLOOD LOSS OF 95CC. 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 59 YR Other