BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1973848 · Received January 14, 2011

    Report

    Report Number
    3003464075-2011-00003
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION AS THE CARTRIDGE'S PASSED THE PRIME AND ALARMS TESTING PRIOR TO INITIATING TREATMENT. THE REPORTED BLOOD LOSS EVENTS ARE ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK OF THE PT'S BLOOD DUE TO AIR VISIBLE IN THE EXTRACORPOREAL BLOOD CIRCUIT OR CLOTTING. THE CYCLER ALARMED APPROPRIATELY TO THE PRESENCE OF AIR. AIR ALARMS AT THE START OR END OF TREATMENT ARE MOST LIKELY THE RESULT OF THE OPERATOR INTRODUCING AIR INTO THE DISPOSABLE CIRCUIT WHILE MAKING PT CONNECTIONS FOR TREATMENT OR RINSEBACK. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING ALARMS AND MAKING PT CONNECTIONS. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING THREE ROUTINE HEMODIALYSIS TREATMENTS, THE OPERATOR WAS UNABLE TO RESOLVE ALARMS IN A TIMELY MANNER, IN TWO TREATMENTS, THE OPERATOR COULD NOT RESOLVE VENOUS AIR ALARMS AND IN THE THIRD TREATMENT, THE ACTUAL ALARM WAS NOT SPECIFIED. EACH TREATMENT WAS ENDED WITHOUT RINSEBACK OF THE PATIENT'S BLOOD, RESULTING IN AN APPROXIMATE BLOOD LOSS TOTALING 520CC. THE PATIENT'S HEMOGLOBIN WAS CHECKED AT THE END OF THE MONTH AND WAS 7.8 G/DL. THE PATIENT'S ROUTINE 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 0087717

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other