Company: B Braun Medical, Inc.
Date of Enforcement Report: 9/25/2013
Class l:
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. Recall Number Z-2188-2013
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 has stopped. The issue can potentially be observed in some Outlook ES pump models 300ES and 400ES with Compact Flash card. It is possible that under infusion could occur because the user may see a visual indication that the pump is running when it is not. B. Braun Medical Inc. has identified that not all of the affected Outlook ES pumps were listed in the original notification of this field correction. Although these pumps were not identified in the previous notice, these pumps were upgraded, if available, during field services.
RECALLING FIRM/MANUFACTURER
B Braun Medical, Inc., Carrollton, TX on 11/14/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6,919
DISTRIBUTION
Nationwide
___________________________________
