BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP MC WIFI CA

    MDR report key: 22643746 · Received July 29, 2025

    Report

    Report Number
    3004548776-2025-00315
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    December 16, 2024
    Report Date
    October 27, 2025
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: (B)(6) 2022: ERROR DURING FORCE SENSOR CALIBRATION. ERROR22-0002 ACCORDING TO TECHNICAL MANUAL: CHECK J9 CONNECTOR ON CPU BOARD [DETACHED] J9 AND ATTACHED IT BACK THE SAME ERROR APPEARS; "(B)(6) 2024: PUMP FOUND DURING SHOP MOVE AND DROPPED AT MY DESK. PUMP HAS BEEN FULLY DISASSEMBLED AND LEFT IN A CARDBOARD BOX. CANNOT REASSEMBLE PUMP AT THIS TIME AS HARDWARE IS MISSING. (B)(6) 2024: REASSEMBLED PUMP AS HARDWARE IS NOW AVAILABLE. ALMOST ALL SCREWS WERE MISSING ALONG WITH CARD-TO-CARD RIBBON CABLE. FORCE BUTTON WAS BROKEN ON PLUNGER HEAD AND WOULD NOT LATCH WHEN FINGERS ARE OPENED AND CLICK TO RELEASE WHEN DEPRESSED. MISSING GREY SCREW CAPS FOR SYRINGE WINGS HOLDER. ORDERING PARTS FROM FK (B)(6) 2024: COMPLETED PM AND REPLACED MISSING SCREW CAPS. PM COMPLETED USING AGILIA PARTNER VERSION V2R 4.0.3.21072WI-FI CONFIGURED SQL AND CENTERIUM SERVER CHECKED FOR CONNECTIVITY AND DATA DOWNLOAD: PASS. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED WITH THE REPORTED ISSUE WAS FOUND. DEVICE LOG WAS NOT PROVIDED; THEREFORE NO REVIEW COULD BE PERFORMED. THE REPORTED DEVICE AND THE DEFECTIVE SPARE PART WERE NOT RETURNED TO OUR LABORATORY FOR ANALYSIS. AS A RESULT, NO INVESTIGATION COULD BE CONDUCTED, AND THE REPORTED EVENT COULD NOT BE REPRODUCED OR CONFIRMED BY OUR LABORATORY. BASED ON THE AVAILABLE INFORMATION AND THE FACT THAT THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE OF THE REPORTED ISSUE REMAINS UNKNOWN (NOT RETURNED). HOWEVER, THE COMPLAINT HAS BEEN REGISTERED FOR STATISTICAL MONITORING. IF FURTHER INFORMATION ARE PROVIDED LATER ON, WE WILL RE-OPEN THE COMPLAINT AND PURSUE THE INVESTIGATION. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: NOT INVESTIGATED. THE TREND IS: NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061431 AGILIA SP MC WIFI CA INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. Z018734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown