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U.S. Department of Health and Human Services

Class 2 Device Recall Outlook ES Safety Infusion System

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 Class 2 Recall
Outlook ES Safety Infusion System
see related information
Date Posted September 06, 2013
Recall Status1 Open
Recall Number Z-2164-2013
Recall Event ID 64146
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: 621-100ES, 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.
Code Information Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580. Multiple serial numbers affected. Affected serial numbers were notified of this field correction.
Recalling Firm/
Manufacturer
B Braun Medical, Inc.
1601 Wallace Dr Ste 150
Carrollton, Texas 75006-6690
For Additional Information Contact Phillip La Croix
972-245-2243
Manufacturer Reason
for Recall
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm decided to conduct a field correction to correct the issue and carried it out through routine field services. The firm was notified by FDA that this is a reportable event, so they notified their consignees via letters dated 10/31/2012.
Quantity in Commerce 1,970 pumps added for this expansion
Distribution Nationwide Distribution.
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.
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