BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC RO

    MDR report key: 20645991 · Received November 8, 2024

    Report

    Report Number
    3004548776-2024-00432
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 31, 2024
    Report Date
    December 26, 2024
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: AT THE BEGINNING OF INFUSION PROCESS, THE ERROR MESSAGE "ERROR 17-0080 BATTERY CHARGE" APPEARED ON DEVICE SCREEN. TO OUR INFORMATION, NO PATIENT HAVE BEEN AFFECTED BY THE REPORTED DEVICE. 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 AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE HISTORY LOG WAS REVIEWED. SEVERAL TECHNICAL ERROR 17 WERE FOUND WHICH CONFIRMS THE REPORTED EVENT. THE REPORTED DEVICE WAS NOT RETURNED TO BRÉZINS FOR INVESTIGATION AS REPAIRS WERE CARRIED OUT LOCALLY. ACCORDING TO PROVIDED INFORMATION, THE BATTERY IS FUNCTIONAL BUT THE BRACKET AND THE MAINS BOARD (Z179372) WERE FOUND DEFECTIVE. THEIR REPLACEMENTS SOLVED THE ISSUE. DESPITE SEVERAL REQUESTS FOR PARTS RETURN, NO ADDITIONAL INFORMATION WAS PROVIDED. FROM COMPLAINT DESCRIPTION IT SEEMS THAT THE ROOT CAUSE OF THE EVENT COULD BE LINKED TO A DEFECTIVE BRACKET AND MAIN BOARD, BUT THIS CANNOT BE CONFIRMED WITHOUT PROPER INVESTIGATION TEST IN BRÉZINS. HOWEVER, IF WE DO GET INFORMATION LATER ON WE MAY RE-OPEN THE COMPLAINT AND PURSUE THE INVESTIGATION. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: VALID. THE TREND IS: NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849229 AGILIA VP MC RO INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. Z019648

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown