BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1817220 · Received August 10, 2010

    Report

    Report Number
    1817220
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 10, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    ALARIS PUMP WAS ALARMING AIR IN TUBING. OPENED CHAMBER DOOR, HALOPERIDOL (HAL) WAS SPRAYING OUT. CLEAR TUBING SEPARATED FROM THE BLUE PLASTIC PORT ON THE TOP OF THE PUMP. HAL STOPPED NEONATAL NURSE PRACTITIONER (NNP) CALLED. TUBING AND HAL DISCONNECTED FROM PATIENT AND CLEAR MAINTENANCE FLUIDS ORDERED AND HUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS IV TUBING FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 WK