BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP MC WIFI AU

    MDR report key: 25008050 · Received April 27, 2026

    Report

    Report Number
    3000240707-2026-00161
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 27, 2026
    Manufacturer
    FRESENIUS VIAL S.A.S
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: "BTS HAS RECEIVED A (B)(6) REGARDING A FRESENIUS KABI AGILIA SP THAT ALLEGEDLY OCCURRED ON (B)(6) 2026 AT 13:00 IN (B)(6) EMERGENCY DEPARTMENT AND IS DESCRIBED AS FOLLOWS: "PATIENT WAS COMMENCED ON FENTANYL 10 MCG/HR POST INTUBATION. ESTIMATED PATIENT'S BODY WEIGHT 90 KG WAS ENTERED INTO ADULT SETTING IN SYRINGE PUMP. CARE THEN HANDED OVER TO RN AFTER AUTHOR WAS ASKED TO ASSIST FOR INTUBATION IN RESUS 1. AROUND 14:00 HRS, ED PHARMACIST FOUND THAT FENTANYL WAS BEING ADMINISTERED AT INCORRECT SETTING OF '10 MCG/KG/HR'. PHARMACIST THEN CHANGED RATE TO 1.1 MCG/KG/HR. PHARMACIST, ED SHIFT CO-ORDINATOR AND THE AUTHOR TRIED INVESTIGATING HOW THE ERROR OCCURRED. WE TRIED BROWSING HISTORY OF EVENTS IN THE PUMP. WE ALSO TRIED CHANGING SETTINGS TO PAEDIATRIC CRITICAL CARE, WHICH DIDN'T ALLOW US TO ADMINISTER FENTANYL -MCG/KG/HR. WE CANNOT ESTABLISH THE INCORRECT SETTING. WE CANNOT ESTABLISH HOW THE SETTINGS CHANGED TO 10 MCG/KG/HR. TECHNICAL/ ELECTRICAL GLITCH." THE PICTURE: 1- WAS TAKEN OF THE PUMP AT THE TIME OF THE INCIDENT, AFTER THE DELIVERY RATE WAS REDUCED. BTS RECEIVED 2 PUMPS THAT COULD'VE POTENTIALLY BEEN INVOLVED IN THIS INCIDENT, AND I HAVE BEEN TRYING TO REPLICATE THE SCREEN SEEN IN THE PHOTO 1, BUT OUR ADULT PROFILES DO NOT ALLOW WEIGHT OF THE PATIENT TO BE ENTERED. THE PAEDIATRIC PROFILE DOES ALLOW FOR WEIGHT TO BE ENTERED, BUT THE DISPLAY SCREEN DOES NOT LOOK LIKE THE PICTURE FROM THE INCIDENT. 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
    356543 AGILIA SP MC WIFI AU INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S Z018792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown