Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primar

FDA device recall Z-2188-2013 · posted 2013-09-13 · Terminated

Recall details

Recalling firm

B Braun Medical, Inc.

Reason for recall

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

Action taken

The firm, B Braun Medical Inc, sent an "Urgent Expanded Medical Device Field Correction" letter dated November 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that pumps that have been upgraded (software version 151599 or higher), no additional action is required on their part at this time. For the pumps that have not yet been upgraded, within three weeks of the letter, customers should confirm the serial numbers using the enclosed response form or contact B. Braun Medical, Inc. Infusion Systems Customers Support at 1-800-627-7867 (800-627-PUMP) to schedule their upgrade. For questions regarding this recall call 972-245-2243.

Root cause

Software design

Status

Terminated

Product code

FRN

Quantity affected

6,919

Distribution

Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.

Date initiated

2012-11-14

Date posted

2013-09-13

Date terminated

2015-03-06

Location

Carrollton, TX

Related 510(k) clearances