Baxter Healthcare Corporation of Deerfield, Illinois issued a voluntary Class I recall of four models of the Automix Automated Nutrition Compounder Systems on July 13, 2012, according to a U.S. Food and Drug Administration (FDA) announcement.
A Class I recall, categorized by the FDA, is the most serious recall that can be issued. It applies to products that have a “reasonable probability” of causing serious injury or death to those who use them.
Compounders are used to mix and administer a variety of total parenteral nutrition (TPN) solutions to patients. TPN is a way to feed a patient by bypassing the digestive system and delivering nutrition by drip into a vein.
The company recalled the devices because fluids such as water, cleaning solutions and nutrition source solutions could enter the device’s keypads and cause intermittent electrical failures. This could result in:
- Nutritional solutions being pumped into patients without being programed to do so
- The device stopping compounding the solution before it was properly mixed, possibly causing incorrect volumes, incorrect solutions and solution incompatibilities
In highly vulnerable people, critical components of TPN like potassium chloride and calcium chloride being improperly mixed or measured could have grave or fatal consequences for patients.
The models and product codes of the recalled systems are:
- Automix High Speed Compounder System 2M8077
- Automix Plus High Speed Compounder System 2M8075
- Automix 3+3 Compounder System 2M8286 and 2M8286K
- Automix 3+3 Compounder System with Accusource Monitoring System 2M8287
The device manufacturer sent “Urgent Product Recall” letters to their customers on July 13 and Aug. 22.
The company recommended that those customers who need more time to change to a different system “closely evaluate the need” to use the compounder in higher risk populations, including children, the elderly or patients with kidney damage.
Source: FDA
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