BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2510547 · Received March 27, 2012

    Report

    Report Number
    3003464075-2012-00018
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 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 ALARMS AND SUBSEQUENT BLOOD LOSS ARE ATTRIBUTED TO ISSUES WITH THE PT'S CATHETER. THE CYCLER ALARMED APPROPRIATELY. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    VENOUS PRESSURE HIGH ALARMS AND BLEEDING AT THE VENOUS SITE OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK OF THE PT'S BLOOD WAS NOT PERFORMED RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PT'S HB DECREASED FROM 11.8 G/DL ON (B)(6) 2012 TO 9.8 G/DL ON (B)(6) 2012. EPOGEN WAS INCREASED BY 3,000 UNITS. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other