BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1354998 · Received March 31, 2009

    Report

    Report Number
    3003464075-2009-00148
    Event Type
    Injury
    Date Received
    March 31, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 2, 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 PERFORMING RINSEBACK IN A TIMELY MANNER AS DIRECTED IN THE USER'S GUIDE FOLLOWING AN UNRECOVERABLE ALARM. THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVALUATION. THE EXACT CAUSE OF THE ALARM CANNOT BE DETERMINED. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. OCCASIONAL ALARMS DURING DIALYSIS ARE EXPECTED AND SHOULD NOT RESULT IN A BLOOD LOSS IF DEVICE LABELING INSTRUCTIONS ARE FOLLOWED. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS 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 WASTE BAG PRESSURE HIGH ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT, WHICH COULD NOT BE RESOLVED BY THE OPERATOR. TREATMENT WAS ENDED WITHOUT PERFORMING RINSEBACK DUE TO POSSIBLE CLOTTING, 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 8117706

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other