BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC WIFI CA

    MDR report key: 16325014 · Received February 8, 2023

    Report

    Report Number
    3000240707-2023-00040
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 9, 2023
    Report Date
    July 8, 2023
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG HISTORY WAS NOT PROVIDED THEREFORE NO REVIEW COULD BE PERFORMED. THIS COMPLAINT WAS REGISTERED AS PART OF REPORTED EVENTS SENT BY CANADIAN SELF-SERVED CUSTOMERS. A DEFECTIVE AIR SENSOR WAS SUSPECTED AND WAS REPLACED. THE DEFECTIVE PART WAS SENT TO BRÉZINS FOR FURTHER INVESTIGATION. SEVERAL FUNCTIONAL TESTS WERE PERFORMED AND A DRIFT OF VALUE WAS DETECTED. THIS FAILURE IS DUE TO THE AIR SENSOR SUBASSEMBLY, WHICH HAS EITHER A DEGRADATION OF THE CERAMIC BONDING OR THE CERAMIC ITSELF. AN INTERNAL CAPA IS OPEN TO ADDRESS THE SUBJECT OF "DEFECTIVE AIR SENSOR". TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS VALID. THE TREND IS ABNORMAL. THE REPORTED RISK IS LOWER COMPARED TO THE ESTIMATED RISK. FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED AN ACTION.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: "AIR BUBBLES IN LINE." FK CANADA SERVICE DEPOT HAS REPLACED THE AIR DETECTOR KIT AS PART OF THE REPAIRS PERFORMED. FK (B)(6) IS AWAITING THE ARRIVAL OF THE PART TO PERFORM AN EVALUATION. REPORTING DUE TO THE REFERENCED ISSUE; NO SERIOUS INJURIES WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230825 AGILIA VP MC WIFI CA INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown