BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 400ES

    MDR report key: 2460047 · Received February 3, 2012

    Report

    Report Number
    2460047
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 3, 2012
    Manufacturer
    B BRAUN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    RN STARTED NIPRIDE DRIP AT 2210 (BP: 216/106). 2218 PATIENT FOUND UNRESPONSIVE, MEDICAL EMERGENCY TEAM (MET) CALL CALLED, PATIENT'S BP DOWN TO 63/41. ACCORDING TO PUMP, NIPRIDE DRIP SET AT 0.5 MCG/KG/HR, 14.3 ML/HR. ACCORDING TO PUMP, PATIENT ONLY RECEIVED 1ML OF DRIP, WHEN LOOKING AT BAG; PATIENT HAD CLEARLY RECEIVED OVER HALF OF THE BAG. WITHDREW REMAINING AMOUNT OF MEDICATION TO MEASURE, AND PATIENT HAD RECEIVED 178.5 ML TOTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK 400ES INFUSION PUMP FRN B BRAUN 400ES *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR