BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP MC WIFI CA

    MDR report key: 19386846 · Received May 23, 2024

    Report

    Report Number
    3000240707-2024-00156
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 11, 2024
    Report Date
    August 19, 2024
    Manufacturer
    FRESENIUS VIAL S.A.S
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: DISPLAYED FORCE ERROR ON SCREEN, 220-0004 REPLACED DEFECTIVE PLUNGER KIT ASSEMBLY. RAN THROUGH THE CALIBRATION AND TESTS, AND ALSO RAN SEVERAL TEST IV'S. ALL TESTS OKAY. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL 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 LOG WAS NOT PROVIDED, THEREFORE NO REVIEW COULD BE PERFORMED. "THE REPORTS DEVICE AND THE DEFECTIVE SPARE PART WERE NOT RETURNED TO OUR LABORATORY FOR ANALYSIS. AS A RESULT, NO FURTHER INVESTIGATION COULD BE CONDUCTED, AND THE REPORTED EVENT COULD NOT BE REPRODUCED OR CONFIRMED BY OUR LABORATORY. BASED ON THE AVAILABLE INFORMATION AND THE FACT THAT THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE OF THE REPORTED ISSUE REMAINS UNKNOWN (NOT RETURNED). HOWEVER, THE COMPLAINT HAS BEEN REGISTERED FOR STATISTICAL MONITORING. IF FURTHER INFORMATION ARE PROVIDED LATER ON WE WILL 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 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 THIS COMPLAINTS HAS BEEN REPORTED AS MDR TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863228 AGILIA SP MC WIFI CA INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown