BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDFUSION

    MDR report key: 12882043 · Received November 29, 2021

    Report

    Report Number
    12882043
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    November 20, 2021
    Report Date
    November 23, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE NOTED PATIENT TO BE TACHYCARDIC. WALKED INTO THE ROOM AND FOUND CONTINUOUS MILRINONE SYRINGE EMPTY. MEDFUSION 4000 PUMP # 2021672 BOLUSED FULL 50ML VOLUME OF MILRINONE INFUSION OVER APPROXIMATELY 30 MINUTES. PUMP WAS PROGRAMMED CORRECTLY FOR THE CONTINUOUS INFUSION RATE 0.55MCG/KG/MIN OR 1ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781941 MEDFUSION PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 180 DA Male Other| R