BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERONEB PROX

    MDR report key: 5871203 · Received August 12, 2016

    Report

    Report Number
    5871203
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    August 7, 2016
    Report Date
    August 8, 2016
    Manufacturer
    AEROGEN LTD
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOTED MEDICATION WAS BUILDING UP IN THE NEBULIZER AND NOT BEING NEBULIZED TO THE PATIENT. THERE WAS APPROXIMATELY 4-6ML OF LIQUID IN THE NEBULIZER; ESTIMATED PATIENT WAS NOT RECEIVING THE FLOLAN FOR APPROXIMATELY 30-45 MINUTES, BASED ON FLOLAN SYRINGE PUMP SET AT 8ML/HOUR. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524134 AERONEB PROX NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD PROX AP-1405592

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR