BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX FLEXFLOW SYSTEM

    MDR report key: 7975671 · Received October 17, 2018

    Report

    Report Number
    3007137787-2018-00005
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 18, 2018
    Report Date
    November 16, 2018
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    UDI-DI
    07332414112387
    PMA / PMN Number
    K071854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION CONFIRMED THE BLOOD LEAK WITHIN THE CIRCUIT. THERE WERE NO SIGNS OF DAMAGE TO THE CIRCUIT. THE FILTER WAS REMOVED FROM THE CIRCUIT AND TESTED FOR LEAKS. A SINGLE FIBER WAS IDENTIFIED AS LEAKING (OUT OF APPROXIMATELY 900 FIBERS). THE SUSPECT FIBER WAS ISOLATED AND INJECTED WITH DYE TO DETERMINE LOCATION ONCE THE FILTER CASE WAS REMOVED. THE FILTER CASE WAS REMOVED, AND THE SUSPECT FIBER LOCATED. THE SUSPECT FIBER WAS CONFIRMED TO BE BROKEN. ANALYSIS OF THE DEVICE CONFIRMED A FILTER FIBER BREAK AND ASSOCIATED BLOOD LEAK CONTAINED WITHIN THE CIRCUIT. TESTING OF DEVICES FROM OTHER LOTS WAS UNABLE TO RECREATE THE REPORTED EVENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE SUSPECT DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THERAPY WITH THE AQUADEX FLEXFLOW SYSTEM, A BLOOD LEAK WAS DETECTED. THE BLOOD LEAK OCCURRED WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED WITHIN 20 MINUTES OF CIRCUIT USE. THE UF 500 BLOOD CIRCUIT WAS REPLACED WITH A NEW CIRCUIT AND THERAPY WAS RESUMED.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED FOR INVESTIGATION. INVESTIGATION IS IN PROCESS. FOLLOW-UP WILL BE SUBMITTED PENDING RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THERAPY WITH THE AQUADEX FLEXFLOW SYSTEM, A BLOOD LEAK WAS DETECTED. THE BLOOD LEAK OCCURRED WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED WITHIN 20 MINUTES OF CIRCUIT USE. THE UF 500 BLOOD CIRCUIT WAS REPLACED WITH A NEW CIRCUIT AND THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816573 AQUADEX FLEXFLOW SYSTEM ULTRAFILTRATION SYSTEM KDI CHF SOLUTIONS, INC. UF 500 7966 07332414112387

    Patients

    Seq Age Sex Outcome Treatment
    1 Other