BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX FLEXFLOW

    MDR report key: 12982899 · Received December 13, 2021

    Report

    Report Number
    12982899
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 6, 2021
    Report Date
    December 1, 2021
    Manufacturer
    NUWELLIS INC.
    Product Code
    KDI
    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

    PATIENT ON AQUAPHERESIS SETTINGS OF BLOOD FLOW 20 AND UF (ULTRAFILTRATION) RATE 200 (CORRECT SETTINGS), CORRECT AT 1500. AT 1540, MACHINE DISCOVERED TO BE AT SETTINGS OF BLOOD FLOW 40, UF RATE 0. SETTINGS CHANGED BACK TO ORIGINAL SETTINGS. PER MACHINE MENU, SEEMS TO HAVE BEEN SET TO WRONG SETTINGS FOR SOMEWHERE BETWEEN 20 AND 40 MIN. NEITHER BEDSIDE NURSE, BUFFER, BREAK NURSE, OR DIALYSIS NURSE MANUALLY CHANGED SETTINGS. TOTAL FLUID REMOVAL AND TREATMENT TIME STILL READING AS THEY SHOULD FOR THE DAY¿S DIALYSIS RUN. PATIENT APPEARS UNHARMED, AND UF RATE INCREASED TEMPORARILY TO MAKE UP FOR SOME OF THE GAINS. PATIENT'S BP (BLOOD PRESSURE) REMAINED WNL (WITHIN NORMAL LIMITS). MACHINE SETTING RESET ITSELF RN (REGISTERED NURSE) ARE NOT SURE WHY THE AQUADEX CONSOLE RESET ITSELF, NO ONE WITNESSED OR TOUCHED THE CONSOLE DURING THAT TIME. PCM (PATIENT CARE MANAGER) REACHED OUT TO VENDOR OF THE ISSUE, UNABLE TO GET AN ANSWER. AQUADEX CONSOLE WILL BE SHIPPED BACK TO MANUFACTURER FOR ANALYSIS. THERE WAS NO HARM DETECTED. THIS IS NOT A RECURRING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887398 AQUADEX FLEXFLOW DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NUWELLIS INC. 114158

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Male