BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1020740 · Received March 27, 2008

    Report

    Report Number
    3003464075-2008-00141
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK PER FACILITY PROTOCOL. NO PROBLEMS WERE FOUND DURING EVAL OF THE RETURNED CYCLER. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS TO PERFORM POWER FAILURE RECOVERY OF THE CYCLER. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. FACILITY STAFF HAS BEEN NOTIFIED. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. 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 POWER FAILURE OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR WAS UNABLE TO RECOVER. RINSEBACK WAS NOT PERFORMED, PER FACILITY POLICY, 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. CYC-D2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other