BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION PC UNIT

    MDR report key: 14470607 · Received May 20, 2022

    Report

    Report Number
    MW5109817
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    March 14, 2020
    Report Date
    March 24, 2020
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 50 ML IV INFUSION PROGRAMMED TO RUN OVER TWO HOURS (25 ML/HR). APPROXIMATELY 22 MINUTES LATER, ADMINISTERING NURSE NOTICED THAT THE ENTIRE 50ML HAD INFUSED INTO PATIENT. REVIEW OF INFUSION PUMP PROGRAMMING PRIOR TO ADMINISTRATION REVEALED ALL APPROPRIATE STEPS WERE FOLLOWED BY NURSING STAFF. PC UNIT AND CHANNEL WERE IMMEDIATELY REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342490 CAREFUSION PC UNIT PUMP, INFUSION FRN CAREFUSION 303, INC. 8015
    342491 CAREFUSION PUMP MODULE SET, ADMINISTRATION, INTRAVASCULAR FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention