BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SMARTFLOW

    MDR report key: 22133892 · Received June 3, 2025

    Report

    Report Number
    3007137787-2024-00003
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    December 6, 2024
    Report Date
    December 12, 2024
    Manufacturer
    NUWELLIS, INC.
    Product Code
    KDI
    UDI-DI
    10853072007029
    PMA / PMN Number
    K192756
    Removal / Correction Number
    TO BE ASSIGNED
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) HAD AN EXCESSIVE WEIGHT MISMATCH ALARM AFTER 40 HOURS OF THERAPY. NURSE RECEIVED "UF BAG FULL" ALARM. NURSE ONLY EMPTIED HALF THE BAG BECAUSE IT OVERFLOWED THE CONTAINER SHE WAS EMPTYING. NUWELLIS RECEIVED A CALL ABOUT THE WEIGHT MISMATCH, AND WE DETERMINED IT WAS BECAUSE SHE DID NOT FULLY EMPTY THE UF BAG BEFORE CONTINUING THERAPY. THE NURSE THEN EMPTIED THE REST OF THE UF ABOUT 15 MINUTES LATER TO HAVE AN EMPTY BAG. THE CALL ENDED. 17 MINUTES LATER WE RECEIVED ANOTHER CALL SAYING THAT THE PATIENT IS HYPOTENSIVE AND 100CC OF FLUID WAS PULLED IN THOSE 17 MINUTES WHEN UF IS SET AT 30CC/HR. BLOOD RETURNED, THERAPY DISCONTINUED, AND PT STABILIZED WITH FLUIDS. WE ASKED THE NURSE IF THE UF PUMP CARTRIDGE WAS IN CLIPPED IN PLACE AND SHE REPLIED YES. HOWEVER, WHEN NURSE WAS TAKING DOWN THE CIRCUIT, SHE NOTICED THAT THE UF CARTRIDGE WAS INDEED LOOSE. WE TOLD HER WE WILL STILL WANT THE CIRCUIT AND CONSOLE BACK AT CORPORATE TO RUN DIAGNOSTICS BUT THE UF CARTRIDGE BEING LOOSE CAN LEAD TO OVER-PULLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851078 AQUADEX SMARTFLOW ULTRAFILTRATION DEVICE KDI NUWELLIS, INC. A06163 UNKNOWN 10853072007029

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Unknown Required Intervention