Baxter (NYSE:BAX) is pulling all Automix nutrition compounding systems in the U.S. over concerns that the devices could fail and deliver dangerous and potentially fatal chemical doses to patients.
The Automix systems provide automated intravenous feeding, pumping nutrients into the body while bypassing the gastrointestinal process.
Baxter recalled its Automix systems after finding that fluids could lead into the keypad and cause electrical failures that affect the Total Parenteral Nutrition solutions delivered to patients.
That could result in patients receiving inappropriate nutrient compounds, or the system may pump nutrition when it’s not meant to, according to the FDA warning.
"The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions (e.g. incorrect volumes, incorrect solutions, and/or solution incompatibilities)," according to the report. "For critical components of TPN, such as Potassium Chloride and Calcium Chloride, large variations in dosing in highly vulnerable patients could lead to serious injury and/or death."
Baxter issued the original product recall last month, reiterating its warning last week to further emphasize the urgency of the recall.
"Baxter recommends that customers discontinue using the Automix compounder and transition to an alternative option as soon as possible," according to a customer letter. "Customers are also being instructed to consider additional quality control measures, such as laboratory analysis of the finished units, to ensure proper concentrations of compounded products."
