BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILIA VP MC WIFI BR

    MDR report key: 23348769 · Received October 21, 2025

    Report

    Report Number
    3000240707-2025-00530
    Event Type
    Death
    Date Received
    October 21, 2025
    Date of Event
    October 5, 2025
    Report Date
    April 6, 2026
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: PATIENT UNDER PALLIATIVE CARE, HOSPITALIZED, PASSED AWAY THE DAY AFTER THE EVENT. EVENT DATE: ON (B)(6) 2025. MEDICAL PRESCRIPTION: MEDICATION WAS PROGRAMMED TO BE INFUSED OVER 24 HOURS; HOWEVER, THE TOTAL VOLUME WAS ADMINISTERED IN APPROXIMATELY 6 HOURS. PREVENTIVE MAINTENANCE: MARCH 2025. WHICH MEDICATION WAS INSTALLED FOR ADMINISTRATION: MIDAZOLAM (PUMP SN: (B)(6)). REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE 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 OBSERVED. DEVICE LOG WAS DOWNLOADED LOCALLY AND PROVIDED FOR ANALYSIS. ACCORDING TO PROVIDED INFORMATION, THE PATIENT CONNECTED TO THIS PUMP, AS WELL AS THE PUMP TREATED IN COMPLAINT (B)(4), DIED THE DAY AFTER THE EVENT. THE REPORTED DEVICE WAS NOT RETURNED TO BRÉZINS FOR INVESTIGATION. DEVICE HISTORY LOG WAS REVIEWED BY OUR INVESTIGATOR IN BRÉZINS. ALL DATA FOUND SHOWED THAT CALCULATED VOLUME MATCHES RECORDED VOLUME. EACH IDENTIFIED INFUSED VOLUMES WERE IN LINE WITH THE DEVICE PROGRAMMING. FLOW RATES CLOSE TO 4 ML/H WERE FOUND BUT INTERSPERSED WITH NUMEROUS MANUAL BOLUSES. THIS MEANT THAT FOR A TOTAL VOLUME OF 84,761ML INFUSED, 69,636ML WERE INFUSED BY BOLUS AND ONLY THE REMAINDER BY 4ML/H INFUSION. AS PER PROVIDED QUALITY CONTROL CERTIFICATE WHICH DATES FROM A FEW MONTHS BEFORE (14 MARCH 2025), NO DYSFUNCTION OF THE DEVICE COULD BE FOUND. APART FROM PROVIDED QUALITY CONTROL CERTIFICATE EDITED UPON LOCAL CHECK OF THE DEVICE, NO OTHER INFORMATION WERE PROVIDED REGARDING ANY EVENTUAL REPAIRS MADE ON THE DEVICE. BASED ON AVAILABLE INFORMATION, THIS COMPLAINT IS CONSIDERED AS NOT VALID WITH NO ISSUE, THE PUMP WORKED AS INTENDED. THIS COMPLAINT IS CONSIDERED AS: NOT VALID. THE TREND IS: N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354726 AGILIA VP MC WIFI BR INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. Z019740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death