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Class 2 Device Recall Outlook ES Safety Infusion System |
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Date Initiated by Firm |
October 24, 2012 |
Date Posted |
September 06, 2013 |
Recall Status1 |
Terminated 3 on July 27, 2015 |
Recall Number |
Z-2163-2013 |
Recall Event ID |
64147 |
Product Classification |
Pump, infusion - Product Code FRN
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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. |
Code Information |
Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. |
Recalling Firm/ Manufacturer |
B Braun Medical, Inc. 1601 Wallace Dr Ste 150 Carrollton TX 75006-6690
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For Additional Information Contact |
972-245-2243
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Manufacturer Reason for Recall |
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
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FDA Determined Cause 2 |
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 in Commerce |
28,427 |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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