BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH'S MEDFUSION 4000 SYRINGE PUMP

    MDR report key: 10017098 · Received May 1, 2020

    Report

    Report Number
    10017098
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    March 15, 2020
    Report Date
    March 24, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDFUSION 4000 SYRINGE PUMP ((B)(4)). PROGRAMMED TO INFUSE CASPOFUNGIN OVER 1 HR, THE SYRINGE PUMP ENDED UP PUSHING THE WHOLE MED OVER 10-15 MINUTES INSTEAD. PARENTS CALLED OUT BECAUSE PUMP WAS BEEPING, AND RN FOUND THE SYRINGE EMPTY, AND DEVICE SHOWING SYRINGE EMPTY ON SCREEN. THE SETTING FOR CASPOFUNGIN HAS THE LOWEST TIME LIMIT OF 1 HR, SO MEDICATION ADMINISTRATION WAS PROGRAMMED CORRECTLY, BUT THE PUMP PUSHED IT FASTER THAN PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482349 SMITH'S MEDFUSION 4000 SYRINGE PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 4380 DA