—#115425

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES.

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: B Braun Medical, Inc.
Address: 1601 Wallace Dr, Ste 150, Carrollton, Texas 75006-6690

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2012-10-24
Posted by FDA: 2013-09-06
Terminated: 2015-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115425. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.