BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2091008 · Received May 3, 2011

    Report

    Report Number
    3003464075-2011-00046
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 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

    FACILITY STAFF ATTRIBUTED THE ALARMS TO PROBLEMS WITH THE PT'S ACCESS. THE CYCLER ALARMED APPROPRIATELY. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    ARTERIAL AIR AND VENOUS AIR ALARMS OCCURRED ONE WEEK APART DURING TWO ROUTINE HEMODIALYSIS TREATMENTS, WHICH COULD NOT BE RESOLVED BY THE OPERATOR. BOTH TREATMENTS WERE DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC FOR EACH. THE PT'S HGB LEVEL WAS 10.3 G/DL ON (B)(6) 2011, AND DECREASED TO 8.7 G/DL ON (B)(6) 2011. THE PT'S ARANESP WAS INCREASED ON (B)(6) 2011, FROM 60 MCG EVERY TWO WEEKS TO 100 MCG EVERY TWO WEEKS. NO OTHER MED 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-171-B 0117704

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other