Company: B Braun Medical, Inc.
Date of Enforcement Report: 9/18/2013
Class lI:
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.
Recall Number Z-2164-2013
REASON
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD – HOLD key strokes are performed on the pump key panel while the user is in the Dose Data Entry screen, or in specific circumstances when the HOLD key is used to silence the KYO alarm at the end of a DOSE Mode infusion. The issue can potentially be observed in Outlook ES pump models 100ES, 200ES, 300ES and 400ES with management processor software versions prior to 151580. It is possible that an under or overdose situation could occur because the user can inadvertently remove previously programmed dose limit values for the selected drug and user notification will not be generated if these dose values are exceeded. B. Braun Medical Inc. has identified that not all of the affected Outlook ES pumps were listed in the original notification of this field correction. Although these pumps were not identified in the previous notice, these pumps were upgraded, if available, during a routine field service. This follow up notification is to ensure that all pumps have been identified.
RECALLING FIRM/MANUFACTURER
B Braun Medical, Inc., Carrollton, TX on 10.312012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,970 pumps added for this expansion
DISTRIBUTION
Nationwide
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