BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICU MEDICAL PRIMARY PLUM SET

    MDR report key: 24414048 · Received February 23, 2026

    Report

    Report Number
    MW5184207
    Event Type
    Other
    Date Received
    February 23, 2026
    Date of Event
    February 10, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVING FIFTH WEEKLY DOSE OF PACLITAXEL. AT A RATE OF 301 ML/HR, IT WAS NOTED THAT THERE WAS A LEAK AT THE FILTER CASSETTE OF THE ICU MEDICAL PRIMARY PLUM SET ASSUMED TO BE LOT#14338132.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472534 ICU MEDICAL PRIMARY PLUM SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other PACLITAXEL