BETHESDA, MD 29 August 2012—Problems with the Automix line of automated nutrition compounders are serious enough that Baxter Healthcare Corporation on August 22 recommended that hospitals not use those devices.
The recommendation, part of a letter (PDF) to pharmacy directors, hospital administrators, and others, follows the company's decision in mid-July to recall all Automix compounders from the U.S. market by June 1, 2013.
Baxter said facilities as soon as possible should use a means other than an Automix compounder to prepare parenteral nutrient solutions.
Those facilities needing time to change their method of compounding parenteral nutrient solutions must complete a "Certificate of Medical Necessity" to continue receiving support and service for their Automix compounder. The company has set deadlines of September 12 to request the certificate and October 12 to return it.
Baxter recommended that those facilities needing to continue using their Automix compounder seriously consider the possible risks to pediatric patients, elderly patients, and patients with renal impairment.
According to information from FDA, Automix compounders may improperly mix solutions as a result of an incorrect key-press response or intermittent electrical failure.
The agency classified Baxter's recall as a class 1 recall.