BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2010635 · Received February 24, 2011

    Report

    Report Number
    3003464075-2011-00020
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY TO THE PRESENCE OF AIR. AIR ALARMS AT THE START OF TREATMENT ARE TYPICALLY DUE TO INADEQUATE AIR REMOVAL DURING PRIME OR AIR ENTERING THE SYSTEM WHEN MAKING PT CONNECTIONS. THE PT'S STANDARD EPOGEN DOSE WAS INCREASED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    VENOUS AIR ALARMS OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED BY THE OPERATOR. RINSEBACK WAS NOT COMPLETED DUE TO THE AMOUNT OF AIR IN THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 141 CC. THE PT'S HGB LEVEL DECREASED FROM 11.4 G/DL ON (B)(6) 2011 TO 9.9 G/DL ON (B)(6) 2011. THE PT'S STANDARD EPOGEN DOSE WAS INCREASED FROM 10,000 UNITS 1X/WK TO 20,000 UNITS 1X/WK. 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 0097702

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other