BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP KR

    MDR report key: 20568915 · Received October 30, 2024

    Report

    Report Number
    3004548776-2024-00425
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 30, 2024
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: ERROR 51 OCCURRED. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THIS IS A KNOWN ISSUE FOR WHICH THE ROOT CAUSE HAS BEEN INVESTIGATED AS PART OF A CAPA. CORRECTIVE ACTIONS ARE CURRENTLY BEING IMPLEMENTED IN THE MANUFACTURING PROCESS. NO DEVICE LOG REVIEW, NOT NECESSARY SINCE THIS IS A KNOWN ISSUE WITH IDENTIFIED ROOT CAUSES. "ERROR 51 ON THE AGILIA CONNECT RANGE IS A KNOWN ISSUE FOR WHICH AN INTERNAL CAPA WAS OPENED IN MAY 2023. THE INVESTIGATION INTO THIS ERROR HAS SHOWN THAT ITS ROOT CAUSES ARE MAINLY RELATED TO TWO COMPONENTS: FLEXIBLE IC FLEX BINDER ASSEMBLY (WHICH INCLUDES THE SPEAKER AND BINDER SOCKET) AND POWER SUPPLY BOARD (FOR AGILIA SP & VP). IT IS RECOMMENDED TO REPLACE THESE PARTS IF THIS ERROR OCCURS. FURTHER INVESTIGATIONS ARE ONGOING, AND CORRECTIVE ACTIONS ARE BEING IMPLEMENTED AND TRACKED WITHIN THE CAPA TO RESOLVE THIS TYPE OF ISSUE. THIS COMPLAINT HAS BEEN ADDED TO OUR TREND FOR STATISTICAL MONITORING." THIS COMPLAINT IS CONSIDERED AS VALID. THE TREND IS NORMAL. THE REPORTED RISK IS LOWER COMPARED TO THE ESTIMATED RISK. FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED AN ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167516 AGILIA SP KR INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. Z018595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown