BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 23476052 · Received November 5, 2025

    Report

    Report Number
    23476052
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALBUMIN HUNG ON FRESH POST-OP HEART. WHEN STARTED IN IV PUMP ALBUMIN BEGAN LEAKING EVERYWHERE AT PUMP SITE AND FROM INFUSION SET/TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637292 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 2420-0007 25065378

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male