BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI PC-2TX

    MDR report key: 360501 · Received November 7, 2001

    Report

    Report Number
    2016493-2001-00280
    Event Type
    Injury
    Date Received
    November 7, 2001
    Date of Event
    August 9, 2001
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL ADVISED THAT DOPAMINE WAS SET UP TO INFUSE AT 20 MICROGRAMS PER KGM PER MINUTE (APPROXIMATELY 9 - 10 MLS/HR). AN ALARM SOUNDED AND AN INTERNAL MESSAGE SCROLLED IN THE DISPLAY. THE PUMP SHUT DOWN. THE USER RESTARTED THE PUMP SUCCESSFULLY AFTER APPROXIMATELY 20 - 30 SECONDS, AT THIS POINT THE PATIENT REQUIRED RESUSCITATION. RESUSCITATION WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49681 GEMINI PC-2TX INFUSION PUMP/CONTROLLER FRN ALARIS MEDICAL SYSTEMS 1320 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention