BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMAT MC AGILIA AUS

    MDR report key: 21598119 · Received March 13, 2025

    Report

    Report Number
    3004548776-2025-00204
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 17, 2025
    Report Date
    July 28, 2025
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: WHEN DISCONNECTING IV GTN INFUSION LINE FROM PT, GTN INFUSION STILL RUNNING CONTINUOUSLY. ACCIDENTAL FINDING OF FAULTY AGILIA PUMP, WHEN DISCONNECTING IV GTN INFUSION LINE FROM PT, GTN INFUSION STILL RUNNING CONTINUOUSLY (PUMP WAS ON PAUSED STATUES AS WITNESS BY MED REG.) APPROX 100-150MLS OF INFUSION ADMINISTERED. RAPID RESPONSE FOR HYPOTENSIVE. CLOSE MONITORING OF BP. REPORTING AS A CONSERVATIVE MEASURE. NO 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. AS SERIAL NUMBER INDICATES A PRODUCTION DATE IN APRIL 2008, IT IS VERY UNLIKELY THAT THIS EVENT COULD BE LINKED TO A PRODUCTION OR MANUFACTURING ISSUE. DEVICE LOG WAS DOWNLOADED LOCALLY AND PROVIDED FOR ANALYSIS. THE REPORTED DEVICE WAS NOT RETURNED TO BRÉZINS FOR INVESTIGATION. DEVICE HISTORY LOG WAS REVIEWED BY OUR INVESTIGATOR IN BRÉZINS AND NOTHING WAS FOUND THAT COULD CONFIRM THE REPORTED EVENT. ALL DATAS FOUND SHOWED THAT CALCULATED VOLUME MATCHES RECORDED VOLUME. EACH IDENTIFIED INFUSED VOLUMES WERE IN LINE WITH THE DEVICE PROGRAMMING. ACCORDING TO PROVIDED SERVICE REPORT (PERFORMED ON (B)(6) 2025), PHYSICAL DAMAGES WAS FOUND ON THE PUMP WHICH MEANT, AMONG OTHER THINGS, CHANGING THE DOOR LEVER AND THE MEMBRANE. BASED ON AVAILABLE INFORMATION, ALTHOUGH IT CANNOT BE CONFIRMED, A USABILITY ISSUE IS SUSPECTED AS A POTENTIAL ROOT CAUSE OF THIS EVENT. THIS COMPLAINT IS CONSIDERED AS: MISUSE. THE TREND IS: N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482331 VOLUMAT MC AGILIA AUS INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. Z019192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown