BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 6016400 · Received October 11, 2016

    Report

    Report Number
    6016400
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    June 3, 2016
    Report Date
    September 25, 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 FIRST HALF OF THIS YEAR, 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
    668886 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 5300

    Patients

    Seq Age Sex Outcome Treatment
    1