BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE

    MDR report key: 4202722 · Received October 23, 2014

    Report

    Report Number
    4202722
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    NXSTAGE MEDICAL INC
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIRST DAY OF HOME HEMO TRAINING USING NXSTAGE, PT STARTED SNEEZING AT START OF TREATMENT. PT THEN BECAME SOB AND ANXIOUS. PT STATES HE CANNOT BREATHE. TREATMENT STOPPED. 911 CALLED. O2 APPLIED, BENADRYL 50MG IV PUSH GIVEN, SALINE CONNECTED TO VENOUS LINE SOLUMEDROL 100MG IV GIVEN. PT STILL SOB. TOOK HOME ALBUTEROL INHALER. EMT ARRIVED, FACEMASK O2 AND NEBULIZER STARTED. B/P 250/129, O2 SAT 68. PT WAS ABLE TO BREATHE ONCE NEBULIZER STARTED. O2 WAS 92%. PT STOOD TO GET ON GURNEY. PT TAKEN TO LOCAL HOSPITAL PER EMT. PT REMAINED ALERT DURING ENTIRE EPISODE. MFR REF: 3003464075-2014-00014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677346 NXSTAGE CAR. 170C SYSTEM ONE KDI NXSTAGE MEDICAL INC 40177028

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening