BEUDAMED
    FDA Recall Terminated

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    Recall: Z-2175-2013 · Initiated December 5, 2012

    Recall

    Recall Number
    Z-2175-2013
    Event Number
    64150
    Firm
    B Braun Medical, Inc.
    FEI Number
    1641965
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 5, 2012
    Posted
    September 10, 2013
    Terminated
    October 24, 2014
    Address
    1601 Wallace Dr, Ste 150, Carrollton, TX, 75006-6690

    Description

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    Reason

    B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on

    Action

    The firm, B. Braun Medical Inc., sent an "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter dated December 05, 2012 to its customers. The letter describes the product, problem and actions taken. The firm finished performing "field upgrades" on March 20, 2010 for this issue. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Infusion Systems Customer Service at 1-800-627-7867 (627-PUMP).

    Distribution

    Worldwide Disribution: USA (nationwide) and country of: Canada.

    Quantity

    14,161