Events

Recall of Device Recall 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
    64152
  • Event Risk Class
    Class 1
  • Event Number
    Z-2188-2013
  • Event Initiated Date
    2012-11-14
  • Event Date Posted
    2013-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115432
  • 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
    This notice is being provided in follow up to the field correction initiated by b. braun medical inc. on august 26, 2011 due to an issue in which the outlook es safety infusion system may halt infusion but the "run" light emitting diodes (leds) on the front display continue to advance as if the pump were infusing. the pump emits a backup alarm, but there are no visual indicators that the infusion.
  • Action
    The firm, B Braun Medical Inc, sent an "Urgent Expanded Medical Device Field Correction" letter dated November 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that pumps that have been upgraded (software version 151599 or higher), no additional action is required on their part at this time. For the pumps that have not yet been upgraded, within three weeks of the letter, customers should confirm the serial numbers using the enclosed response form or contact B. Braun Medical, Inc. Infusion Systems Customers Support at 1-800-627-7867 (800-627-PUMP) to schedule their upgrade. For questions regarding this recall call 972-245-2243.

Device

Device Recall Outlook ES Safety Infusion System
  • Model / Serial
    Model number: 621-300ES and 621-400ES. Multiple serial numbers affected.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.
  • 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 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