BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICU MEDICAL PRIMARY PLUM SET

    MDR report key: 24431500 · Received February 24, 2026

    Report

    Report Number
    MW5184335
    Event Type
    Other
    Date Received
    February 24, 2026
    Date of Event
    February 18, 2026
    Report Date
    February 18, 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 DOSE OF FAM-TRASTUZUMAB DERUXTECAN INFUSION AND AFTER ONLY 1.7 ML INFUSED OF PRIMED VOLUME, LEAK OCCURRED AT THE FILTER SITE. LOT #13984986.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499705 ICU MEDICAL PRIMARY PLUM SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 14255-28 13984986

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other FAM-TRASTUZUMAB DERUXTECAN.