BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILIA SP MC BR

    MDR report key: 19885371 · Received August 1, 2024

    Report

    Report Number
    3000240707-2024-00313
    Event Type
    Death
    Date Received
    August 1, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 20, 2025
    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: HOSPITAL INFORMS THAT THE PUMP DID NOT WORK, CAUSING A DEATH IN THE NEONATAL UNIT OF THE VITÓRIA APART HOSPITAL, AN INTERNAL ANALYSIS OF THE PUMPS HAS BEEN REQUESTED. HISTORICAL REPORT. MEDICATIONS: VASOPRESSIN TOTAL VALUE 9.6 ML, INFUSE: 0.2 ML/H IN 24 HOURS, INSTALLED AT 18:00 AND DOBUTAMINE TOTAL VALUE 4.8 ML, INFUSE 0.1 ML/H IN 24 HOURS, INSTALLED AT 08:00. AT 10:00 THE INFUSION WAS INCREASED TO 02.ML/H. IN TELEPHONE CONTACT WITH THE INITIAL NOTIFIER, SHE SAID THAT THE PUMPS WERE NOT WORKING AND THE PROGRAMMED VOLUMES HAD NOT BEEN ADMINISTERED, BUT THAT SHE WOULD CHECK MORE INFORMATION WITH THE DEPARTMENT RESPONSIBLE FOR THE PATIENT'S DIRECT CARE. THE PATIENT SUFFERED CARDIORESPIRATORY ARREST AND DIED. WE ARE IN CONTACT WITH THE CLIENT TO VERIFY MORE INFORMATION ABOUT THE REPORT. THE REPORT RECEIVED MENTIONS BOTH THE AGILIA SP MC BR, SERIAL NUMBER (B)(6), AND THE AGILIA INJECTOMAT SERINGA PUMP, SERIAL NUMBER (B)(6), HOWEVER IT DOES NOT CLARIFY WHICH DRUG WAS PROGRAMMED IN EACH PUMP. WHEN WE RECEIVE MORE INFORMATION, WE WILL SHARE IT IN THE COMMUNICATION. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EVENT 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 FOUND. DEVICE HISTORY LOG WAS REVIEWED AND DATA EMBEDDED IN HISTORY LOG IS INSUFFICIENT TO CONFIRM THE REPORTED EVENT. "THE REPORTED DEVICE WAS NOT RECEIVED IN BRÉZINS FOR INVESTIGATION AND THE ANALYSIS WAS CARRIED OUT USING THE HISTORICAL DATA PROVIDED. ACCORDING TO OUR INVESTIGATION OF THE EVENT LOGS, THERE WERE NO INSTANCES OF THE PUMPS STOPPING UNEXPECTEDLY. ADDITIONALLY, THERE WERE NO ISSUES WITH THE INFUSION RATES, NEITHER OVERFLOW NOR UNDERFLOW WAS DETECTED. HOWEVER, IT IS IMPORTANT TO NOTE THAT THE HISTORICAL DATA RECEIVED DOES NOT COVER THE ENTIRE DURATION OF THE OPERATION. FOR A MORE THOROUGH INVESTIGATION, WE REQUIRE A COMPLETE HISTORICAL REPORT. FOR THIS COMPLAINT, WITHOUT THE DEVICE PHYSICALLY NO ADDITIONAL TESTS COULD BE PERFORMED AND IT IS IMPOSSIBLE FOR US TO CONFIRM THE REPORTED EVENT AND NO ROOT CAUSE COULD BE IDENTIFIED. HAVING NOT RECEIVED MORE INFORMATION ABOUT SENDING A MORE COMPLETE HISTORY LOG, THE COMPLAINT WILL BE CLOSED AND MAY BE REOPENED IF NEW INFORMATION IS RECEIVED." THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE TREND IS NORMAL. THE REPORTED RISK IS LOWER COMPARED TO THE ESTIMATED RISK FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED NO ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249215 AGILIA SP MC BR INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death