BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUADEX FLEX FLOW SYSTEM

    MDR report key: 930587 · Received April 30, 2007

    Report

    Report Number
    3003504604-2007-00001
    Event Type
    Death
    Date Received
    April 30, 2007
    Date of Event
    April 1, 2007
    Report Date
    April 30, 2007
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    PMA / PMN Number
    K013733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ULTRAFILTRATION IS THE PROCESS OF REMOVING EXCESSIVE FLUID FROM THE BODY BY REMOVING FLUID FROM THE INTRAVASCULAR SPACE THROUGH A VENOUS ACCESS. EACH PASS THROUGH THE CIRCUIT REMOVES A SMALL AMOUNT FLUID FROM THE BLOOD CAUSING A CLINICALLY INSIGNIFICANT INCREASE IN THE HEMATOCRIT. IF THE UF RATE IS THE SAME AS THE RECRUITMENT RATE FROM THE INTERSTITIAL SPACES, THERE IS NO NET CHANGE IN THE INTRAVASCULAR BLOOD VOLUME. USUALLY PATIENTS WITH A UF RATE OF LESS THAN 300 ML/HR TOLERATE THIS RATE WITHOUT ANY PROBLEMS; HOWEVER, THIS PATIENT EXHIBITED SYMPTOMS OF LOW BLOOD VOLUME (HYPOTENSION) WITH RATES LESS THAN 50 ML/HR OBVIOUSLY DUE TO HIS POOR CARDIAC OUTPUT. THE TREATMENT FOR HYPOTENSIVE EPISODES IN THIS PATIENT WAS TO TURN OFF THE UF PUMP AND ONLY LET THE BLOOD CIRCULATE THROUGH THE CIRCUIT WITHOUT REMOVING ANY FLUID. WHILE ON UF THERAPY, THE PATIENT DID EXPIRE. THE ATTENDING PHYSICIAN STATED THAT THERE WAS NO DIRECT OR INDIRECT CAUSE OF EXPIRY DUE TO THE THERAPY OR THE AQUADEX CONSOLE. THE COMPANY DIRECTOR OF CLINICAL AFFAIRS FOLLOWED UP WITH THE PHYSICIAN TO VERIFY THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EXPIRY AND THE ATTENDING PHYSICIAN AGAIN STATED NO. THE INVESTIGATION WILL BE CLOSED AS THE TOTAL SYSTEM HAS PERFORMED WITHIN REQUIRED SPECIFICATIONS AND AS INTENDED. THE HEALTH FACILITY WILL BE MONITORED AS PART OF ROUTINE COMPLAINT HANDLING AND REPORTING PROCEDURES. THE COMPANY AND THE FACILITY CONSIDER THIS INVESTIGATION CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    BACKGROUND: A REPORT WAS GENERATED FROM A COMPANY SALES REPRESENTATIVE AND NOT THE HOSPITAL. A PHONE CALL INFORMED THE DIRECTOR OF QUALITY ASSURANCE THAT A PATIENT TREATED WITH THE AQUADEX FLEX FLOW CONSOLE EXPIRED. THE HOSPITAL WAS CALLED AND INDICATED THE PRODUCT WORKED AS INTENDED AND THE HOSPITAL DID NOT PLAN ON REPORTING THIS TO THE COMPANY AS A RESULT. RETURNED PRODUCT ANALYSIS: PER THE HOSPITAL ATTENDING PHYSICIAN THE PRODUCT DID NOT MALFUNCTION, THEREFORE, THE PRODUCT WAS NOT RETURNED AND REMAINS AT THE FACILITY WORKING AS INTENDED. THE CIRCUIT USED FOR THIS THERAPY WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUADEX FLEX FLOW SYSTEM AQUADEX FLEX FLOW CONSOLE KDI CHF SOLUTIONS, INC. A1100 #212 OR #267

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death