BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL

    MDR report key: 1950776 · Received December 30, 2010

    Report

    Report Number
    MW5018799
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    September 3, 2010
    Report Date
    December 30, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF FOUND - PUMP DELIVERED CONTENTS - MORPHINE- OF THE SYRINGE PROGRAMMED FOR 24 HRS WITHIN 3 HRS. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: NEWBORN, SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITHS MEDICAL MEDFUSION 3000 SERIES SYRINGE PUMP FRN SMITHS MEDICAL MEDEX/3500 361208425

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA