BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADEX FLEXFLOW SYSTEM

    MDR report key: 7975716 · Received October 17, 2018

    Report

    Report Number
    3007137787-2018-00006
    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
    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. THERE WERE NO SIGNS OF DAMAGE AND THE DEVICE WAS VERIFIED TO BE WITHIN CALIBRATION AS-FOUND. THE AQUADEX CONSOLE BLOOD LEAK DETECTOR WAS TESTED AS-FOUND BY SIMULATING THERAPY AND ALARMED AS DESIGNED WHEN BLOOD SAMPLES RANGING FROM 1%-29% HEMATOCRIT WERE PASSED THROUGH THE DETECTOR. AN IN-HOUSE CONTROL CONSOLE BLOOD LEAK DETECTOR WAS USED TO CONFIRM THE ANALYSIS. ANALYSIS OF THE DEVICE WAS UNABLE TO CONFIRM THE REPORTED CONDITION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE 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, THE CONSOLE DID NOT GIVE A BLOOD LEAK DETECTED ALARM.

    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, THE CONSOLE DID NOT GIVE A BLOOD LEAK DETECTED ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813908 AQUADEX FLEXFLOW SYSTEM ULTRAFILTRATION SYSTEM KDI CHF SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other