Events

Recall of Outlook ES Safety Infusion System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B Braun Medical, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59848
  • Event Risk Class
    Class 1
  • Event Number
    Z-0051-2012
  • Event Initiated Date
    2011-09-07
  • Event Date Posted
    2011-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103860
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    B braun outlook es safety infusion system "run" light emitting diodes (leds) pumps stop infusing and a backup alarm sounds, but the "run" leds advance as if the pumps were infusing.
  • Action
    B. Braun Medical, Inc. sent an "URGENT: FIELD CORRECTION" letter dated September 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. A firm representative will contact all affected customers in order to schedule the field correction. The correction consists of revising the Door and Main Processor software, inspecting the main board, and replacing the board, if warranted. A Field Correction Information Form was included in the letter for customers to complete and return. Contact Technical Product Support at 1-800-627-7867 for questions regarding this notice.

Device

Outlook ES Safety Infusion System
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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: 621-300ES, 621-400ES, 621-400ESR. || To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
  • Manufacturer
    B Braun Medical, Inc

Manufacturer

B Braun Medical, Inc
  • Manufacturer Address
    B Braun Medical, Inc, 1601 Wallace Dr Ste 150, Carrollton TX 75006-6690
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA