BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2120441 · Received June 3, 2011

    Report

    Report Number
    3003464075-2011-00070
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 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 EVENT IS ATTRIBUTED TO OPERATOR ERROR. FACILITY STAFF HAVE PROVIDED RE-TRAINING. THE USER'S GUIDE CONTAINS ADEQUATE WARNINGS ABOUT ADJUSTING THE VASCULAR ACCESS WHILE THE BLOOD PUMP IS RUNNING, WHICH MAY RESULT IN A SIGNIFICANT BLOOD LOSS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT, THE VENOUS FISTULA NEEDLE WAS DISLODGED WHILE TRYING TO ADJUST IT RESULTING IN A BLOOD LOSS OF APPROX 190 CC OF BLOOD. THE PHYSICIAN INCREASED THE STANDARD EPO DOSE FROM 10,000 UNITS/WEEK TO 12,000 UNITS/WEEK ON (B)(6) 2011. NO OTHER MEDICAL INTERVENTION PROVIDED.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other