BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1915799 · Received November 30, 2010

    Report

    Report Number
    3003464075-2010-00124
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVIDENCE OF A DEVICE MALFUNCTION. CLINICAL STAFF ATTRIBUTED EVENT TO AN ALLERGIC REACTION. THE USER'S GUIDE INCLUDES ADEQUATE WARNINGS TO MONITOR FOR POTENTIAL ALLERGIC REACTIONS. BIOCOMPATIBILITY OF DEVICE HAS BEEN ESTABLISHED. PT CONTINUES TO DIALYZE WITH SYS ONE AND NO FURTHER SIMILAR PROBLEMS REPORTED USING A DIALYZER FROM A DIFFERENT MFR. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    APPROX 5 MINS INTO A PT'S FIRST ROUTINE HEMODIALYSIS TREATMENT WITH NXSTAGE SYS ONE, THE PT COMPLAINED OF "SOMEONE STEPPING ON MY CHEST", DIFFICULTY BREATHING, AND ITCHING. THE TREATMENT WAS DISCONTINUED WITHOUT RINSING BACK PT'S BLOOD; 50MG OF IV BENADRYL AND OXYGEN, 3L, VIA NASAL CANNULA WERE ADMINISTERED. PT WAS TRANSPORTED TO EMERGENCY ROOM, GIVEN STEROIDS AND OBSERVED; HE WAS LATER SENT HOME.

    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 0017707

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention