BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1050297 · Received May 22, 2008

    Report

    Report Number
    3003464075-2008-00218
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 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 OF THE PT'S BLOOD AS INSTRUCTED IN THE USER'S GUIDE. THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVALUATION. THE EXACT CAUSE OF THE ALARM CANNOT BE DETERMINED. OCCASIONAL ALARMS DURING HEMODIALYSIS TREATMENTS ARE EXPECTED AND SHOULD NOT RESULT IN BLOOD LOSS IF DEVICE LABELING INSTRUCTIONS ARE FOLLOWED. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. FACILITY STAFF WAS NOTIFIED OF THE EVENT. 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. A SYSTEM ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR CHOSE NOT THE PERFORM RINSEBACK, 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 8017707

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other