BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMAT MC AGILIA US

    MDR report key: 19316018 · Received May 14, 2024

    Report

    Report Number
    3000240707-2024-00157
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 14, 2024
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTING THE DEVICE IS DUE FOR A PM. HE/CUSTOMER ALSO HAVING ISSUES WITH IV PUMP OVERDUE FOR ITS FACTORY PM. DURING THE IV PUMPS PM, THE MEASURED AVERAGE FLOW RATE FAILED AT: 94.94 ML/HR. ALSO DURING PM, THE MEASURED VOLUME FAILED AT: 23.53 ML. PLEASE REPAIR/CALIBRATE DEFECTIVE IV PUMP. ADDITIONAL INFO FROM FRESENIUS KABI US SERVICE: RECEIVED PUMP (B)(6). DEVICE DUE FOR PREVENTIVE MAINTENANCE. REPLACED BATTERY PACK AND MEMBRANE. FLOW RATE AND PRESSURE SENSORS REQUIRED CALIBRATION. NEW PM DUE DATE IS 05/092027. EQUIPMENT CLEANED, POST SERVICE TESTED AND RELEASED FOR USE. 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
    482638 VOLUMAT MC AGILIA US INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown