BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 5999407 · Received October 5, 2016

    Report

    Report Number
    5999407
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    July 19, 2016
    Report Date
    September 13, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS REPRESENTATIVE AS ONE OF 230 REPAIRS MADE BY THE BIOMEDICAL DEPARTMENT OVER THE PAST 7 MONTHS, RELATED TO CRACKED AND BROKEN BEZELS AND/OR DOORS ON THE CARE FUSION ALARIS IV PUMP. IF THE DAMAGED DOOR IS NOT DETECTED BEFORE IT ENTIRELY DISINTEGRATES OR FALLS OFF, THE PUMP WILL POTENTIALLY DELIVER FREE FLOW MEDICATIONS LEADING TO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652209 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO