BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2831131 · Received November 2, 2012

    Report

    Report Number
    3003464075-2012-00081
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 6, 2012
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL STAFF ATTRIBUTED EVENT TO AN ALLERGIC REACTION. THE USER'S GUIDE INCLUDES ADEQUATE WARNING TO MONITOR FOR POTENTIAL ALLERGIC REACTIONS. BIOCOMPATIBILITY OF DEVICE HAS BEEN ESTABLISHED. THE CARTRIDGE WAS NOT RETURNED FOR EVAL PRECLUDING FURTHER INVESTIGATION. NO SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS CARTRIDGE LOT. THIS APPEARS TO BE A RANDOM ISOLATED EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    APPROX THREE MINS INTO PT'S FIRST HEMODIALYSIS TREATMENT ON THE NXSTAGE SYS ONE THE PT EXPERIENCED A DECREASE IN HIS BLOOD PRESSURE, 120-140 SYSTOLIC TO 40 SYSTOLIC, AND HE COMPLAINED OF A "LITTLE MORE TROUBLE BREATHING". DOPAMINE GTT WAS INCREASED AND NOREPINEPHRINE WAS ADDED; WITHIN 30-60 MINS PT'S BLOOD PRESSURE IMPROVED. A TRYPTASE LEVEL WAS DRAWN AND RESULTS INDICATED AN ALLERGIC REACTION. NO OTHER MEDICAL INTERVENTION WAS 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-500 2057801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R