By Bruce Japsen | Baxter International Inc. said it is recalling an in-home dialysis
device that has been linked to serious injury reports and at least one
death in the last two years, the company said.

The U.S. Food and Drug Administration has classified the recall as a
Class I recall, the agency’s most serious, for Baxter’s HomeChoice and
HomeChoice Pro peritoneal dialysis cyclers because the device is causing
an “overfill” of fluid in the patient’s abdomen.

A Class I recall means the FDA wants the company to address the problems.  “The action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of the device,” the company said in a statement.

Baxter said it is working to address the problem with a software update that will include additional messages and alarms in hopes of reducing the “risk of excessive accumulation of fluid in the peritoneal cavity.” Improved labeling and additional training on how to use the device is also part of Baxter’s corrective action plan, the company said.

The medical term for the injury is known as “increased intraperitoneal volume,” or IIPV. It can result in death or serious injury from conditions that include abdominal hernias, heart failure, acute hypertension and decreased pulmonary function, Baxter said in a statement.

“Children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate,” Baxter said in a statement. “Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.”

HomeChoice devices will remain on the market remain, Baxter said, because the product “continues to be safe and effective” if instructions are followed.

Annual sales of HomeChoice devices are about $45 million, a fraction of Baxter’s total company sales of more than $12.5 billion.