BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOMAT MC AGILIA D

    MDR report key: 21778253 · Received April 4, 2025

    Report

    Report Number
    3004548776-2025-00229
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 16, 2025
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED WITH THE REPORTED ISSUE WAS FOUND. THE DEVICE LOG WAS REVIEWED AND DID NOT SHOW ANY MALFUNCTION CORRESPONDING TO THE COMPLAINT DESCRIPTION. FROM ON (B)(6) 2025, THE INFUSION WAS ON PROPOFOL DRUG WITH A PAUSE AND NO DRUG CHANGE AFTER THE PAUSE (NO DYSFUNCTION DETECTED). ON (B)(6) 2025, AN INFUSION ON MIDAZOLAM WAS DONE WITHOUT ANY DYSFUNCTION. AFTER THAT, THE PROPOFOL WAS SELECTED AGAIN UNTIL ON (B)(6) 2025. ON (B)(6) 2025 AT 04:02:24, AFTER A PAUSE OF 241S (AROUND 4 MIN) THE "PDK - STANDARDLSG" DRUG WAS SELECTED AN INFUSION STARTED @5 ML/H BUT IT WAS STOPPED IMMEDIATELY AFTER ONLY 0.008 ML WERE INFUSED. THEN, AT 04:05:10, THE DEVICE WAS SWITCHED OFF. THE REPORTED DEVICE WAS RECEIVED IN BRÉZINS FOR INVESTIGATION. ACCORDING TO OUR INVESTIGATION, TRACES OF IMPACT WERE FOUND ON THE HOUSING DURING THE VISUAL INSPECTION. REPRODUCTION TESTS BASED ON THE COMPLAINT DESCRIPTION WERE PERFORMED ON THE DEVICE. THE DEVICE WAS SWITCHED ON USING THE MAINS SUPPLY. A BRAUN PERFUSOR 50CC SYRINGE WAS INSTALLED AND AUTOMATICALLY DETECTED. PROPOFOL DRUG AND PATIENT WEIGHT WERE SELECTED. THE FLOWRATE WAS SET TO 9.3 ML/H, AND THE PAUSE FUNCTION WAS ACTIVATED FOR 9 HOURS. AFTER 4 MINUTES, THE SYRINGE CLAMP WAS OPENED, THE BRAUN PERFUSOR 50CC SYRINGE WAS INSTALLED AGAIN, AND AUTOMATICALLY SELECTED. THE DEVICE DISPLAYED "PROPOFOL" (XMG/ML) ONCE MORE, NOT THE PDK STANDARD. THE SAME INFUSION DETAILS REMAINED DISPLAYED ON THE DEVICE. THIS TEST SEQUENCE WAS REPEATED FIVE TIMES, ALWAYS WITH THE SAME RESULT: PROPOFOL REMAINED PRESELECTED BUT COULD BE MODIFIED MANUALLY (NO AUTOMATIC DRUG SELECTION OCCURRED). THE INTERNAL CHECK REVEALED THAT THE LINEAR SENSOR BECOMES SLIGHTLY DETACHED BUT WAS NOT RELATED TO THE COMPLAINT DESCRIPTION. AS SUCH, NO TECHNICAL ROOT CAUSE COULD BE IDENTIFIED IN RELATION TO THE REPORTED ISSUE. HOWEVER, THE PR-25411 EXISTS ON INJECTOMAT AGILIA RANGE CONCERNING A KNOWN "RANDOM" SOFTWARE BUG. THIS BUG MAY CAUSE THE DRUG NAME TO CHANGE UNEXPECTEDLY AFTER SYRINGE REPLACEMENT AND SYRINGE TYPE VALIDATION. THIS BEHAVIOR DOES NOT OCCUR SYSTEMATICALLY. TO ADDRESS THIS ISSUE, THE RECOMMENDED SOLUTION IS TO SELECT YES ON THE "SAME THERAPY SCREEN" SETTING, WHICH WILL DISPLAY A CONFIRMATION SCREEN AFTER EACH SYRINGE REPLACEMENT TO VERIFY THE DRUG SELECTION. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: NOT CONFIRMED. THE TREND IS: NORMAL.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: THE PATIENT WAS ADMINISTERED PROPOFOL VIA A PERFUSOR (DEVICE ID 14132) WITH A SETTING OF 2.5 MG/KG BW AT A SET WEIGHT OF 75 KG. DURING THE CARE MEASURES, THE PERFUSOR WAS SET TO PAUSE MODE AS THE PERFUSOR SYRINGE WAS EMPTY. AFTER COMPLETION OF THE NURSING MEASURES, A NEW PERFUSOR SYRINGE WITH PROPOFOL WAS PREPARED, CLAMPED INTO THE DEVICE, THE MEDICATION WAS CONFIRMED AND THE APPLICATION WAS STARTED BY PRESSING THE GREEN BUTTON. ACCORDING TO THE EMPLOYEE, THE PERFUSOR SWITCHED TO PDK MODE WITH 5 ML/H WHEN THE GREEN BUTTON WAS PRESSED. WHAT HAS BEEN DONE? THE EMPLOYEE NOTICED THE ERROR IMMEDIATELY THIS, THE AFFECTED PERFUSOR WAS REMOVED FROM OPERATION AND AN ERROR MESSAGE WAS SENT TO THE MEDICAL TECHNOLOGY DEPARTMENT IN THE MORNING. THERE WAS NO DAMAGE TO THE PATIENT. IT IS NOTICEABLE THAT THE PROBLEM OCCURS FROM PAUSE MODE BACK TO START MODE AND THE PDK MODE IS ACTIVATED AT 5ML/H. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605072 INJECTOMAT MC AGILIA D INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. Z018120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown