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.
FDA Recall Z-0051-2012 · Posted 2011-10-18
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Recalling FirmB Braun Medical, Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2011-09-07
Date Terminated2015-05-04
Product Quantity6321
Reason for Recall
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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