BEUDAMED
    FDA Recall Terminated

    Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

    Recall: Z-0007-2012 · Initiated July 20, 2010

    Recall

    Recall Number
    Z-0007-2012
    Event Number
    59847
    Firm
    B Braun Medical, Inc
    FEI Number
    1641965
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 20, 2010
    Posted
    October 3, 2011
    Terminated
    January 7, 2015
    Address
    1601 Wallace Dr, Ste 150, Carrollton, TX, 75006-6690

    Description

    Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

    Reason

    The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel.

    Action

    The firm, B. Braun Medical Inc., sent an "URGENT: FIELD CORRECTION" letter dated September 8, 2011 to its customers. The letter described the product, problem and actions to be taken. The firm informed the customers that a B. Braun representative will be contact ing them to schedule a field software upgrade of the affected pumps. The customers were instructed to complete and return the FIELD CORRECTION INFORMATION FORM via mail using the enclosed envelop and contact B. Braun Customer Service for shipping instructions at 1-800-627-7867 if product is to be returned. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Technical Product Support at 1-800-627-7867 (800-627-PUMP).

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL, GA, IA, IL, KS, KY, LA, MA, MI, MO, NC, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and WV; and country of: Canada.

    Quantity

    11,525 pumps