BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC

    MDR report key: 22350058 · Received June 27, 2025

    Report

    Report Number
    3004548776-2025-00295
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 17, 2025
    Report Date
    February 23, 2026
    Manufacturer
    FRESENIUS VIAL S.A.S
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED COMPLAINTS: 3004548776-2025-00296, 3004548776-2025-00297, 3004548776-2025-00298, 3004548776-2025-00299.

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG HISTORY OF THE RECEIVED PUMP WAS REVIEWED. NO USE OF THE PUMP WAS RECORDED AT THE TIME OF THE EVENT (17 JUNE 2025). THE LAST RECORDED DAY OF USE WAS (B)(4) 2025, AND A FEW AIR ALARMS WERE RECORDED DURING THE DAY, SOME OF WHICH STOPPED INFUSIONS IN PROGRESS. BUT ALTHOUGH THIS COULD CONFIRM THE REPORTED EVENT (AIR IN LINE), THOSE INFORMATION ARE INSUFFICIENT TO CONFIRM A QUALITY ISSUE AS ALARMS ARE DESIGNED TO INFORM THE USER THAT THE INFUSION NEEDS TO BE ATTENDED. ONE OF THE FIVE REPORTED DEVICES WAS RECEIVED IN BRÉZINS FOR INVESTIGATION. NOTHING WAS NOTICED DURING EXTERNAL VISUAL CHECK. DURING DEVICE LOG REVIEW OF THE RECEIVED PUMP, NO USE OF THE PUMP WAS RECORDED AT THE TIME OF THE EVENT (17 JUNE 2025). THE LAST RECORDED DAY OF USE WAS (B)(4) 2025, AND A FEW AIR ALARMS WERE RECORDED DURING THE DAY HOWEVER, THIS IS A FUNCTIONAL ALARM THAT SHOULD TRIGGERIF THERE IS AIR IN THE SET, WITHOUT BEING PRESENT AT THE TIME OF THE EVENT, WE CAN'T SAY WHETHER IT'S A DEFECT IN THE DEVICE. SEVERAL FUNCTIONAL TESTS RELATED TO THE REPORTED EVENT WERE CARRIED OUT. ALL PERFORMED SUCCESSFULLY AND VALUES WERE FOUND COMPLIANT WITH IFU SPECIFICATIONS COMPARED TO SETTINGS. THE REPORTED EVENT COULD NOT BE REPRODUCED AND THERE WAS NO TECHNICAL OR FUNCTIONAL ISSUE THAT COULD BE IDENTIFIED FOR THIS DEVICE WHICH WORKED AS INTENDED. THEREFORE, THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. HOWEVER, BE INFORMED THAT BE INFORMED THAT MORE RECURRENT AIR ALARM ISSUES HAVE BEEN INVESTIGATED AFTER SOFTWARE UPGRADES TO 4.2 OR 4.3 BY R&D TEAM INTO EVENT 2043114. IT HAS BEEN SHOWN THAT THE AIR DETECTION LEVELS OF THE LAST SOFT (SW. 4.2 AND 4.3) HAVE BEEN LOWERED IN ORDER TO BETTER DETECT SMALL BUBBLES (<10L) WHICH WORKS VERY WELL WITH NEW VERSIONS OF AIR SENSORS. THE ISSUE IS THAT WITH SLIGHTLY OLDER AIR SENSORS, THE DETECTION THRESHOLD IS TOO CLOSE TO THE LIMIT, TOO SENSITIVE. THEREFORE, SEVERAL ACTIONS ARE BEING CARRIED OUT. AN FSN HAS BEEN SENT, DEALT BY THE EVENT, FRESENIUS KABI RECOMMENDS TO ALL CUSTOMERS: · WHEN RELOCATING PUMP STATIONS, ALWAYS MOVE THE ROLLING STAND ITSELF, RATHER THAN PULLING ON THE TUBE SETS. · WHEN INSTALLING TUBE SETS, TO USE THE HOOK ON THE LEFT SIDE OF THE PUMP HOUSING TO SECURE THE TUBE SET AND KEEP IT IN PLACE THROUGHOUT THE INFUSION. A SOFTWARE CORRECTION TO PREVENT FROM THESE FALSE AIR ALARMS IS IN PREPARATION, DEALT BY THE EVENT AND CCR. A HARDWARE INVESTIGATION IS ALSO UNDERWAY ON THE AIR SENSORS IN THE FIELD VIA CAPA. WE REMIND YOU THAT BEFORE UPGRADING, IT IS IMPORTANT TO FOLLOW THE (B)(4). THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED, AND THE ROOT CAUSE COULD BE RELATED TO A SOFTWARE ISSUE. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY THIS COMPLAINT IS CONSIDERED AS: NOT CONFIRMED THE TREND IS: ABNORMAL

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: THE PROBLEM WITH NEW PUMPS IS THAT AFTER 30-60 MIN, PUMP WILL START TO HAVE SEVERAL ALARMS FOR THE AIR BUBBLES. THE NURSE REDUCED THE SENSITIVITY OF THE AIR SENSOR, BUT THERE WERE STILL A LOT OF ALARMS, TOO MANY. PROBLEM APPEARS WHEN THEY HAVE HIGHER FLOW RATE, 150 -200 ML/H, NOT WITH LOWER FLOW RATE, 10 - 20 ML/H. THE NURSE INFUSED CITRATE WITH A HIGHER FLOW RATE AND CALCIUM WITH LOWER FLOW RATE. THERE ARE NO AIR BUBBLES IN THE UPPER PART OF THE SET, BUT THEY APPEAR IN THE MIDDLE PART (SILICON TUBE) AND IN THE LOWER PART OF THE SET WHERE BLUE CLAMP IS. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EVENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938931 AGILIA VP MC INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S Z019601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown