BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2077896 · Received April 27, 2011

    Report

    Report Number
    3003464075-2011-00043
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 29, 2011
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4) WAS INITIATED ON AN ICU PT ADMITTED WITH RSV AND INFLUENZA WHO HAD DEVELOPED SEPSIS AND SEPTIC SHOCK. PT HAD BEEN ON (B)(4) FOR ABOUT A WEEK AN HAD BEEN IMPROVING WHEN PT EXPERIENCED A DECREASE IN BLOOD PRESSURE AND URINE OUTPUT CEASED. THE PT WAS WEIGHED AND DETERMINED TO BE 1 KG UNDER THE EXPECTED WEIGHT. PT WAS ADMINISTERED 2 BOLUS OF ALBUMIN AT 20CC/KG AND 2 SALINE BOLUS OF 10-20CC/KG. (B)(4) WAS CONTINUED AND PT IMPROVED. NO OTHER MED INTERVENTION WAS REPORTED. NO OTHER SIMILAR INCIDENTS REPORTED WITH CONTINUED USE OF THE CYCLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CYC-D2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention