BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 19749000 · Received July 16, 2024

    Report

    Report Number
    19749000
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    February 5, 2024
    Report Date
    April 24, 2024
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE BD TRIFUSE EXTENSION SET WAS FOUND LEAKING OUT ONTO THE BED. CONNECTIONS WERE CHECKED AND TIGHTENED, BUT FLUID LEAKING OUT OF THE TRIFUSE PERSISTED. TRIFUSE AND BLUE CAP WERE CHANGED. NO FURTHER ISSUE WITH LINE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523647 ALARIS SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 23352

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown