BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX FLEX FLOW SYSTEM

    MDR report key: 950085 · Received October 29, 2007

    Report

    Report Number
    3003504604-2007-00002
    Event Type
    Injury
    Date Received
    October 29, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 29, 2007
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    PMA / PMN Number
    K013733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 OR CENTRAL ACCESS. THIS SPECIFIC EXPERIENCE WAS CONFIRMED TO HAVE OCCURRED DUE TO OFF-LABEL USE AND AS A RESULT A PREVENTATIVE ACTION HAS BEEN OPENED. A PRODUCT BULLETIN WAS SENT TO THE ACCOUNT WHICH RE-ENFORCES ON -LABEL USE AS WELL AS THE HAZARDS ASSOCIATED WITH TUBING RUPTURES DUE TO EXTENDED THERAPY. A COMPANY CLINICAL REP WAS ALSO SENT TO REINFORCE THE PRODUCT INDICATION FOR USE AND WARNINGS. A REVIEW OF THE THERAPY HISTORY CONCLUDED THAT THE ACCOUNT RAN THE THERAPY BEYOND THE REPORTED 120 HOURS. THE ACCOUNT RAN THE PRODUCT FOR 186 HOURS. THE THERAPY TIME WAS NINE DAYS IN 2007. THE HOURS BREAK DOWN TO THE CIRCUIT BEING RUN FOR 7.75 DAYS WHICH IS CONSIDERED BEYOND THE COMPANY WARNINGS OF NOT RUNNING LONGER THAN 24 HOURS. THE DURATION OF THERAPY CARRIED OUT BY THE HEALTH PROFESSIONAL IS DIRECTLY RESPONSIBLE FOR THE RUPTURE OF THE TUBING. 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 ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    BACKGROUND: THE FIELD EXPERIENCE REPORT (FER) ORIGINATED DUE TO A FIELD EXPERIENCE REPORTS AT MEDICAL CENTER. THE EVENT OCCURRED IN 2007 AND WAS REPORTED EIGHT DAYS LATER, BY A COMPANY CLINICAL REP. THE REPORT INDICATED THE CIRCUIT TUBING RUPTURED CAUSING A LOSS OF BLOOD AFTER RUNNING FOR 120 HOURS AND 47 MINUTES. THE TREATMENT WAS STOPPED AND TWO UNITS OF PACKED RED BLOOD CELLS RBCS WERE INFUSED AFTER A MEASUREMENT FOR HGB OF 11.7. RETURNED PRODUCT ANALYSIS: THE PRODUCT WAS DISCARDED BY THE ACCOUNT AND SUBSEQUENT ATTEMPTS TO RETRIEVE THE PRODUCT WERE NOT SUCCESSFUL. THE ACCOUNT RAN THE PRODUCT FOR 186 HOURS. THE THERAPY TIME WAS NINE DAYS IN 2007. THE COMPANY WARNING RECOMMENDS NOT RUNNING LONGER THAN 24 HOURS. A REVIEW OF THE LOT HISTORY INFO FOR THE CIRCUIT LOT OF 4109 DEMONSTRATE THE PRODUCTS WERE MANUFACTURED AND TESTED TO SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUADEX FLEX FLOW SYSTEM AQUADEX FLES FLOW UF500 CIRCUIT KDI CHF SOLUTIONS, INC. A1650 #4109

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention