BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2514905 · Received March 30, 2012

    Report

    Report Number
    3003464075-2012-00019
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    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 OCCURRENCE OF BOTH ARTERIAL AIR AND ARTERIAL PRESSURE ALARMS AT THE START OF THE TREATMENT INDICATE THAT THE ALARMS ARE MOST LIKELY THE RESULT OF VASCULAR ACCESS FLOW ISSUES. THE CYCLER ALARMED APPROPRIATELY. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER IS DIRECTED IN THE USER GUIDE WHEN AN ALARM CANNOT BE RESOLVED. THE USER GUIDE CONTAINS PROBABLE CAUSES OF ALARMS AND ADEQUATE TROUBLESHOOTING INSTRUCTIONS. A DIRECT CORRELATION BETWEEN THE NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. NO FURTHER SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    ARTERIAL AIR AND PRESSURE ALARMS OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR WAS UNABLE TO COMPLETE RINSEBACK DUE TO THE AMOUNT OF TIME ELAPSED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. PT¿S HB DECREASED FROM 11.1 G/DL ON (B)(6) 2012 TO 9.6 G/DL ON (B)(6) 2012. EPOGEN DOSING WAS INCREASED ON (B)(6) 2012 FROM 5,000 UNITS TO 10,000 UNITS. NO OTHER 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-B 1127739

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other