BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2445277 · Received February 3, 2012

    Report

    Report Number
    3003464075-2012-00009
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY TO AIR IN THE EXTRACORPOREAL CIRCUIT. THE ALARMS AND SUBSEQUENT BLOOD LOSS EVENTS ARE ATTRIBUTED TO THE OPERATOR NOT CLOSING THE SALINE T AS DIRECTED IN ONE INSTANCE AND AIR ENTERING THROUGH THE PT'S ACCESS NEEDLE IN THE OTHER INSTANCE. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    ARTERIAL AND VENOUS AIR ALARMS OCCURRED DURING TWO CONSECUTIVE HEMODIALYSIS TREATMENTS. DUE TO THE AMOUNT OF AIR IN THE CIRCUIT, BOTH TREATMENTS WERE DISCONTINUED WITHOUT PERFORMING RINSEBACK RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC FOR EACH TREATMENT. HB DECREASED FROM 10.7 G/DL IN (B)(6) 2011 TO 9.4 G/DL ON (B)(6) 2012. THE PT'S STANDARD EPOGEN WAS INCREASED FROM 16,000 TO 20,000 UNITS 1XWK. 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 1107702

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other