BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SMARTFLOW

    MDR report key: 24714089 · Received March 30, 2026

    Report

    Report Number
    3007137787-2026-00003
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 26, 2026
    Manufacturer
    NUWELLIS, INC.
    Product Code
    KDI
    UDI-DI
    10853072007104
    PMA / PMN Number
    K192756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTS DEVICE FLUID REMOVAL WAS APPROXIMATELY 20 ML/HR HIGH DURING DAYSHIFT, AND APPROXIMATELY 40 ML/HR HIGH DURING NIGHT SHFIT. CUSTOMER BELIEVES THIS MAY HAVE CONTRIBUTED TO THE PATIENT BECOMING HYPOTENSIVE AND REQUIRING FLUID ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777122 AQUADEX SMARTFLOW AQUADEX KDI NUWELLIS, INC. 120100 10853072007104

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female Required Intervention