BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE 8110 SERIES

    MDR report key: 3161418 · Received June 5, 2013

    Report

    Report Number
    3161418
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION 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

    ALARIS SYRINGE PUMP DID NOT RECOGNIZE THE CORRECT SYRINGE SIZE AND VOLUME TO BE INFUSED. THE PUMP READ THE SYRINGE SIZE AND VOLUME INCORRECTLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INFUSING AMPICILLIN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249276 ALARIS SYRINGE 8110 SERIES PUMP, INFUSION, SYRINGE FRN CAREFUSION 303, INC. 8110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 DAY NO OTHER THERAPIES