BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2070274 · Received April 19, 2011

    Report

    Report Number
    3003464075-2011-00038
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 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

    NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY. THE BLOOD LOSS IS ATTRIBUTED TO POSSIBLE CLOTTING DUE TO THE AMOUNT OF TIME THE BLOOD PUMP WAS STOPPED. THE USER GUIDE INCLUDES INSTRUCTIONS FOR PERFORMING MANUAL RINSE BACK OF THE PATIENT'S BLOOD WHEN TRAINED AND INSTRUCTED BY THE FACILITY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A SYSTEM ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR DISCONTINUED TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE EPOGEN DOSE WAS INCREASED. NO OTHER MEDICAL INTERVENTION WAS PROVIDED.

    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 1017712

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other