Baxter Healthcare Nabs Class I Identity for ExactaMix Inlet Correction

FDA has updated Baxter Healthcare’s ExactaMix automated compounding device inlets correction to identify it as a class I recall in which there have been amendments to the product’s instructions for use (IFU). The recall doesn’t involve removing items from where they are used or sold, instead updating instructions.

The ExactaMix and ExactaMix Pro automated compounding device inlet is a disposable part of the device used in a pharmacy to combine several ingredients into one final solution. The inlets are only to be used with the ExactaMix and are not intended for direct patient hook-up.

Baxter initiated the correction to the inlets after receiving increased reports of particulate matter found within the primary packaging inlet components, including within the sterile fluid path tubing before use, according to the company. The update to the IFU affects only the disposable inlets and not the ExactaMix compounder devices.

If affected product is used, it may cause issues such as a blood clot in the lungs, stroke, damage to the small blood vessels and organs, other serious injuries, and death. Currently, there have been no reported injuries or deaths connected to the problem.

On August 20, Baxter sent all affected customers an Urgent Medical Device Correction letter recommending that pharmacy and clinical staff inspect inlets before use, including the inlet primary packaging, tubing, connectors, and spikes, in accordance with the updated IFU.

The company said not use the inlet if particulate matter is observed and to contact Baxter corporate product surveillance to report a complaint and arrange for product return.

If no particulate matter is seen, the inlet can be used, according to the company, who suggest that users prime the inlet before use in accordance with the instructions provided in the priming and verifying section of the ExactaMix and ExactaMix Pro compounder operator’s manual, which states that users visually inspect for particulate matter during the process and not use the inlet if matter is observed.

Additionally, users should visually inspect the finished solution in the patient bag for precipitates and particulates after compounding, as shown in the fulfilling the order section of the operator’s manual. It is recommended that more than one healthcare professional inspect the final product prior to delivery to a patient.

As for filters, Baxter said to use a minimum of 1.2 micron in-line filter during product administration, which is recommended by the American Society for Parenteral and Enteral Nutrition (ASPEN) for administration of total nutrient admixtures, dextrose-amino acid admixtures, and lipid injectable emulsion. For administration of any solution involving the use of compounding device inlets, use a minimum 1.2 micron in-line filter unless the specified solution requires smaller as part of standard practice.