—#115424

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: 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.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

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: 2012-10-31
Posted by FDA: 2013-09-06
Terminated: 2016-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.