BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2062482 · Received April 7, 2011

    Report

    Report Number
    3003464075-2011-00034
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBLEM FOUND WITH RETURNED CARTRIDGE. 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. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    AT INITIATION OF CRRT THERAPY BURN PT BECAME TACHYCARDIC, HYPERTENSIVE THEN BRADYCARDIC AND PEA (PULSELESS ELECTRICAL ACTIVITY), CPR STARTED, CODED 10 MINS AND WAS REVIVED. PT COMPLAINED OF SEVERE ITCHING AND WAS SEVERELY AGITATED PRIOR TO CODING. ATROPINE AND EPINEPHRINE WERE ADMINISTERED DURING THE CODE; THEN VASOPRESSIN AND EPINEPHRINE DRIPS WERE STARTED. NEXT DAY CRRT INITIATED AGAIN AND PT WAS HYPOTENSIVE; THERAPY WAS DISCONTINUED W/O RETURNING BLOOD. VASOPRESSIN AND EPINEPHRINE DRIPS INITIATED AGAIN. NO OTHER MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 0087801

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention