BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 4180342 · Received October 7, 2014

    Report

    Report Number
    4180342
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A PRETERM BABY BOY WAS ADMITTED FROM THE OPERATING ROOM STATUS POST-TOTAL ANOMALOUS PULMONARY VENOUS RETURN (TAPVR) REPAIR ON DOPAMINE, EPINEPHRINE, MILRINONE, AND CALCIUM DRIPS FOR HEMODYNAMIC SUPPORT. ONE OF THE 4 MODULES ATTACHED TO ONE PC, WITH MILRINONE DRIP INFUSION GAVE AN UNPROVOKED "CHANNEL ERROR" ALARM. THE MODULE KEY PADS WERE UNRESPONSIVE, THUS UNABLE TO RESET THE PUMP.THE MODULE WITH MILRINONE INFUSION AND MAINTENANCE CARRIER IVF WERE DETACHED FROM PC AND QUICKLY ATTACHED TO "RESTORE" SETTINGS. TRANSIENT HYPOTENSION WITH MEAN ARTERIAL PRESSURE (MAP) OF LOW 30'S WAS NOTED AND INTERVENED WITH VOLUME RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629323 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION CORP. 8015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Life Threatening| R