Recall Z-2163-2013 · FRN Pump, Infusion

B Braun Medical, Inc.

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, includi

Date	Sep 6, 2013 (initiated Oct 24, 2012)
Status	Terminated
Reason	B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels
Root cause	Component design/selection
Action	B Braun sent an URGENT: MEDICAL DEVICE FIELD CORRECTION letter dated October 24, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Support at 1-800-627-7867 for questions regarding this notice.
Quantity	28,427
Distribution	Nationwide Distribution.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.