BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP TIVA RO

    MDR report key: 19188875 · Received April 26, 2024

    Report

    Report Number
    3004548776-2024-00118
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 25, 2024
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: AT THE BEGINNING OF INFUSION PROCEDURE, ON THE DEVICE SCREEN THE FOLLOWING ERROR MESSAGE WAS DISPLAYED: "98-0004 UNEXPECTED RESET". ERROR 98 IS IDENTIFIED IN THE TECHNICAL MANUAL AS A DEFECTIVE RESET CIRCUIT. 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
    982868 AGILIA SP TIVA RO INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown