B. Braun Outlook ES Infusion Pumps Recalled for DoseGuard Software Defect
B. Braun Medical Inc. is expanding a field correction for Outlook ES pumps where a specific key sequence can disable dose limit protection.
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 can disable dose limit protection, creating a risk of medication error. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical Inc. is expanding a field correction for the Outlook ES Safety Infusion System. This action follows an initial field correction initiated on August 26, 2011, and adds 1,970 pumps to the recall. The affected devices are used 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 software issue where the Care Area can be inadvertently exited, which removes the DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes is performed on the pump key panel while the user is in the Dose Data mode. The affected units are models 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580.
The affected pumps were distributed nationwide. Affected serial numbers have been notified of this field correction. Healthcare facilities should contact B. Braun Medical Inc. to arrange for the necessary software update or field correction.
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
- 1,970
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 (3)
- Model number: 621-100ES
- 621-200ES
- 621-300ES
Distribution
Distributed nationwide across the United States.
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