BEUDAMED
    FDA Enforcement Class I Terminated

    VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. Volumat MC Agilia can be used with the Dose Error Reduction Software (DERS) Vigilant Drug Lib to define the default and upper hard limits for the Bolus Volume, or dose, by drug. The health care professional can then operate the pump for that drug within the upper hard limits defined in the Drug Library.

    Recall: Z-2064-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2064-2019
    Event ID
    83138
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fenwal Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2019
    Initiation Date
    June 24, 2019
    Classification Date
    August 12, 2019
    Termination Date
    March 6, 2023
    Address
    3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, 60047-8930, United States

    Description

    VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. Volumat MC Agilia can be used with the Dose Error Reduction Software (DERS) Vigilant Drug Lib to define the default and upper hard limits for the Bolus Volume, or dose, by drug. The health care professional can then operate the pump for that drug within the upper hard limits defined in the Drug Library.

    Reason

    The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib

    Code Info

    All serial numbers distributed in the US

    Distribution

    US Nationwide Distribution

    Quantity

    9461 units