BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2132236 · Received June 14, 2011

    Report

    Report Number
    3003464075-2011-00075
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    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 EXACT CAUSE OF THE ALARM CANNOT BE DETERMINED. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR DISCONTINUING TREATMENT WITHOUT PERFORMING RINSEBACK AS INSTRUCTED IN THE USER'S GUIDE. OCCASIONAL ALARMS DURING DIALYSIS ARE EXPECTED AND SHOULD NOT RESULT IN A BLOOD LOSS IF DEVICE LABELING IS FOLLOWED. THE USER'S GUIDE INCLUDES APPROPRIATE ACTIONS TO RESPOND TO ALARMS. THERE HAVE BEEN NO SIMILAR REPORTS SUBSEQUENT TO THIS EVENT. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A HIGH WASTE LINE PRESSURE ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR DISCONTINUED TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. STANDARD EPOGEN DOSE WAS INCREASED FOLLOWING A DROP IN HEMOGLOBIN. ACTUAL HEMOGLOBIN LEVELS AND DATES OF TESTING REQUESTED BUT NOT PROVIDED. NO OTHER MEDICAL INTERVENTION WAS REPORTED.

    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-B 1037720

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other