Baxter International Inc. has recalled a dialysis device that is for in-home kidney dialysis use. Serious injury reports and one death have been connected to this device in the last two years.
According to the Chicago Tribune, “The U.S. Food and Drug Administration has classified the action as a Class 1 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.”
The problem is called increased intraperitoneal volume or IIPV. IIPV can result in serious injury or death from the symptoms of:
- abdominal hernias
- heart failure
- acute hypertension
- decreased pulmonary function
Currently Baxter International Inc. is working to fix the problem with software updates, improved labeling, and additional training on how to correctly use the device at home.
Even with a recall, Baxter has chosen to continue having the HomeChoice device remain for sale on the market.
According to the Chicago Tribune in an interview with Baxter, “the product ‘continues to be safe and effective’ if instructions are followed.”
Affected model include HomeChoice systems model numbers: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR.
If you feel your at-home Baxter HomeChoice or HomeChoice Pro has caused you injury, contact personal injury lawyers at Atkins and Markoff today. Our Oklahoma personal injury lawyers have years of experience handling defective product claims throughout the state of Oklahoma as well as nation wide.