B. Braun Outlook ES Pumps Recalled for Potential Drug Library Loss
B. Braun Medical is recalling Outlook ES pumps because a software issue could cause the drug library to be lost, potentially leading to incorrect medication dosing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software defect could lead to incorrect medication dosing (over- or under-dose). This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling Outlook ES infusion pumps, specifically models 620-100 and 620-200. The recall involves 14,161 units that were distributed nationwide in the United States and in Canada. These devices are intended to regulate the flow of primary and secondary fluids, including blood, lipid, and Total Parenteral Nutrition (TPN), when positive pressure is required.
The recall is due to a field correction previously performed to address the loss of the drug library in the affected pumps. This issue could occur after periods of lost DC (battery) power or out-of-tolerance low power. If the drug library is lost, it could lead to a delay in therapy or the delivery of an over- or under-dose of a therapy if the user relies on the pump's library features.
Healthcare facilities and users of these devices should contact B. Braun Medical, Inc. for information regarding the field correction and any necessary actions to ensure safe operation of the equipment.
The recalled product
- 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…
- Manufacturer
- B Braun Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 14,161
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Models 620-100 and 620-200
- multiple serial numbers
Distribution
Distributed nationwide across the United States.
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