—#115430

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, and 621-200ES. 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
510(k) numbers: K994375
Affected lot / code info: Models 620-100 and 620-200; multiple serial numbers

Why it was recalled

B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on

Root cause (FDA determination)

Component design/selection

Action the firm took

The firm, B. Braun Medical Inc., sent an "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter dated December 05, 2012 to its customers. The letter describes the product, problem and actions taken. The firm finished performing "field upgrades" on March 20, 2010 for this issue. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Infusion Systems Customer Service at 1-800-627-7867 (627-PUMP).

Recalling firm

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

Distribution

Distribution pattern: Worldwide Disribution: USA (nationwide) and country of: Canada.

Timeline

Recall initiated: 2012-12-05
Posted by FDA: 2013-09-10
Terminated: 2014-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115430. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.