BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2142389 · Received June 21, 2011

    Report

    Report Number
    3003464075-2011-00076
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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 ALARM TO CLOTTING OF THE PATIENT'S CATHETER. THE CYCLER ALARMED APPROPRIATELY. THE PATIENT RECEIVED A NEW CATHETER. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN ARTERIAL PRESSURE EXCEEDED ALARM OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT DUE TO CLOTTING OF THE PATIENT'S CATHETER. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK DUE TO VISIBLE AIR IN THE LINES, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. HGB DECREASED FROM 12.0 G/DL PRE EVENT TO 10.0 G/DL POST EVENT. STANDARD EPOGEN DOSING WAS INCREASED FROM 10,000 UNITS TO 15,000 EVERY WEEK. 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 1037707

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other