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
    64147
  • Event Risk Class
    Class 2
  • Event Number
    Z-2163-2013
  • Event Initiated Date
    2012-10-24
  • Event Date Posted
    2013-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115425
  • 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 medical inc. has become aware of an issue with the outlook es safety infusion system. the key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. this issue applies specifically to the hold button. if this occurs, the door processor (dp) will not receive the desired input from the user. this issue can be observed in pumps with key panels.
  • Action
    B Braun sent an URGENT: MEDICAL DEVICE FIELD CORRECTION letter dated October 24, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Support at 1-800-627-7867 for questions regarding this notice.

Device

Outlook ES Safety Infusion System
  • Model / Serial
    Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES.
  • 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: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. 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