BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICU MEDICAL PRIMARY PLUM SET

    MDR report key: 24413884 · Received February 23, 2026

    Report

    Report Number
    MW5184199
    Event Type
    Other
    Date Received
    February 23, 2026
    Date of Event
    February 16, 2026
    Report Date
    February 17, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FIRST PACLITAXEL DOSE FOR THE PATIENT AND AT 200 ML/HR TITRATION, LEAKING FROM THE FILTER/CASSETTE SITE WAS NOTED ON THE ICU MEDICAL PRIMARY PLUM SET WITH LOT#14445268.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472238 ICU MEDICAL PRIMARY PLUM SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other PACLITAXEL