BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2835148 · Received October 26, 2012

    Report

    Report Number
    2835148
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FENTANYL DRIP WAS INFUSING ON A SYRINGE PUMP ON AN INTUBATED INFANT. THE PUMP BEGAN TO ALARM THAT THE PUMP NEEDED TO BE CALIBRATED AND IT THEN SHUT DOWN. A NEW SYRINGE PUMP WAS OBTAINED AND THE DRIP RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP, INFUSION, SYRINGE FRN CARDINAL HEALTH 303, INC. 8110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO