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U.S. Department of Health and Human Services

Class 1 Device Recall Outlook ES Safety Infusion System

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 Class 1 Recall
Outlook ES Safety Infusion System
see related information
Date Posted September 13, 2013
Recall Status1 Open
Recall Number Z-2188-2013
Recall Event ID 64152
Premarket Notification
510(K) Numbers
K011975  K994375 
Product Classification Pump, Infusion - Product Code FRN
Product 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.
Code Information Model number: 621-300ES and 621-400ES. Multiple serial numbers affected.
Recalling Firm/
Manufacturer
B Braun Medical, Inc.
1601 Wallace Dr Ste 150
Carrollton, Texas 75006-6690
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 6,919
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = B. BRAUN MEDICAL, INC.
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