BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX FLEXFLOW

    MDR report key: 11862722 · Received May 21, 2021

    Report

    Report Number
    11862722
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 6, 2021
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AQUADEX FLEXFLOW MACHINE (TL-02596) CONSISTENTLY ALARMED "INFUSION LINE DISCONNECTED", PU AND PI PRESSURES OUT OF RANGE. PATIENT WAS RECEIVING/UNDERGOING AQUAPHERESIS TREATMENT WHEN MACHINE STARTED TO ALARM, WITHIN 15MINS OF STARTING. UNABLE TO SOLVE PROBLEM. WITHIN 15MINS OF AQUAPHERESIS INITIATION, PATIENT'S IJ AND FEMORAL LINE PRESSURES WENT OUT OF RANGE. ALARMED "INFUSION LINE DISCONNECTED", BUT ALL CONNECTIONS WERE TIGHT. ASPIRATED AND FLUSHED BOTH LINES, NO PROBLEMS NOTED. BUT PU WAS STILL NEAR -300 AND PI RAN NEGATIVE, -11. IT'S POSSIBLE THAT THE FILTER WAS CLOTTED, OR IT CAN BE A MACHINE DEFECT. I'M NOT SURE WHAT TO RECOMMEND AS IT COULD HAVE BEEN EITHER A CLOTTED FILTER, OR A MACHINE DEFECT. MACHINE IS PULLED FROM DIFFERENT UNIT AND BROUGHT BACK TO UNIT, IS TAGGED TO BE CHECKED. PATIENT CARE MANAGER (PCM) REACHED OUT TO CHF SOLUTION FOR THE PROBLEM WITH THE MACHINE, ACCORDING TO CHF FROM OUR STATEMENT, "THE INFUSION LINE DISCONNECT IS A PRESSURE RELATED ALARM DOES NOT ONLY OCCUR IF THE LINE IS DISCONNECTED IT CHANGES WITH VESSEL SIZE." IF PATIENT WAS CRYING, THEIR VESSEL SIZE FLUCTUATES. THE CONSOLE IS NOT AN ISSUE PER CHF SOLUTION, WE WILL STILL PULL IT OUT OF SERVICE AND SEND IT OUT SINCE IT IS A RENTAL. THIS DEVICE WAS SENT TO THE MANUFACTURER. THERE WAS NO DETECTABLE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759072 AQUADEX FLEXFLOW DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CHF SOLUTIONS, INC. 114158

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA