BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2132230 · Received June 14, 2011

    Report

    Report Number
    3003464075-2011-00074
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    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

    FACILITY STAFF ATTRIBUTED THE PATIENT'S SYMPTOMS TO A POSSIBLE DIALYZER REACTION. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. NO PROBLEM FOUND WITH RETURNED CARTRIDGE. THE USER'S GUIDE INCLUDES ADEQUATE WARNINGS TO MONITOR FOR POTENTIAL ALLERGIC REACTIONS. BIOCOMPATIBILITY OF DEVICE HAS BEEN ESTABLISHED. CARTRIDGE IS SINGLE USE GAMMA STERILIZED. NO OTHER SIMILAR REPORTS ASSOCIATED WITH THIS LOT. PATIENT CONTINUES TO DIALYZE WITH SYSTEM ONE AND NO FURTHER PROBLEMS REPORTED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT PATIENT EXPERIENCED A RASH AND CLOSING OF THROAT. TREATMENT WAS ENDED AND PATIENT WENT TO ED AND WAS ADMINISTERED PO AND IV BENADRYL AND IV STEROIDS; SYMPTOMS RESOLVED. 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 1037714

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| O