BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3500

    MDR report key: 2060072 · Received April 5, 2011

    Report

    Report Number
    2060072
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 5, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUMP READS CHECK CLUTCH REPEATEDLY. NO MEDICATION GIVEN. HAVE TO WAIT FOR NEW SYRINGE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3500 INFUSION PUMP, SYRINGE FRN SMITHS MEDICAL MEDFUSION 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR