BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500

    MDR report key: 2240745 · Received August 28, 2011

    Report

    Report Number
    2240745
    Event Type
    Malfunction
    Date Received
    August 28, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 28, 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

    SYRINGE PUMP WITH FEEDING SPORADICALLY ALARMED WITH THE WARNING: CHECK CLUTCH /PLUNGER. CLUTCH/PLUNGER CHECKED, NOTHING FOUND TO BE OUT OF PLACE AND FEEDING CONTINUED. AT 1630, THE SYRINGE PUMP ALARMED AGAIN WITH THE SAME WARNING, HOWEVER, DESPITE REPOSITIONING SYRINGE AND MAKING SURE CLUTCH/PLUNGER WERE CORRECTLY PLACED, THE ALARM WOULD NOT CEASE AND FEEDINGS WOULD NOT INFUSE. NEW SYRINGE PUMP OBTAINED AND FEEDINGS INFUSED VIA THAT WITH NO ALARMS THUS FAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO