Recall Overview

On March 2 2010, FDA designated Baxter International's January Feild Corrective Action of HomeChoice and HomeChoice PRO automated peritoneal dialysis cyclers a Class I recall. A Class I recall is the U.S. Food & Drug Administration (FDA) most serious type of recall action, and are usually only issued when a device poses a risk of serious injury or patient death. Baxter and the FDA are conducting the recall of the HomeChoice and HomeChoice PRO devices due to reports of serious injuries and at least one death associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. The recall notice says that Baxter will not be removing the HomeChoice and HomeChoice PRO from the market, however clinicians should weigh the risks and benefits to continued use of these devices. The notice goes on to say that clinicians should also review the prescription settings for patients who continue to use these devices. Model numbers affected by this recall include:

Model	Product Code	Lot Number	Manufacturing Date
HomeChoice	5C4471	All	All
HomeChoice	5C4471R	All	All
HomeChoice	5C4474	All	All
HomeChoice	5C4474R	All	All
HomeChoice	T5C4441	All	All
HomeChoice	T5C4441R	All	All
HomeChoice	5C4474D	All	All
HomeChoice	5C4474DR	All	All
HomeChoice PRO	5C8310	All	All
HomeChoice PRO	5C8310R	All	All
HomeChoice PRO	R5C8320	All	All
HomeChoice PRO	R5C8320R	All	All
HomeChoice PRO	T5C8300	All	All
HomeChoice PRO	T5C8300R	All	All

If you, or someone you love, have been injured using a Baxter HomeChoice or HomeChoice PRO Dialysis Cycler and would like the attorneys at Nolan Law Group to review your potential case, please contact us.

What is Peritoneal Dialysis

Peritoneal dialysis (PD) is a treatment for patients suffering chronic kidney failure. The therapy uses the patient's peritoneum in the abdomen as a membrane across which fluids and dissolved substances (electrolytes, urea, glucose, albumin and other small molecules) are filtered from the blood. A soft tube called a catheter is used to fill the abdomen with a cleansing liquid called "dialysis solution". The walls of the abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from the blood into the dialysis solution. These wastes and fluid then leave the body when the dialysis solution is drained. Several fill – drain cycles are typically needed during a treatment. Automated peritoneal dialysis (PD) systems are prescription medical devices used to regulate this procces automatically. Automated PD systems, like the HomeChoice systems, can be programmed to deliver and remove several cycles of doctor-prescribed amounts of dialysis solution.

What is IIPV?

IIPV is a condition which occurs when there is more fluid in the abdomen than prescribed. The condition is also sometimes called "overfill" and can occur if the prescription parameters on the dialysis device are not programmed appropriately or working properly. IIPV may result in serious injury or death from conditions including abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.

Signs and Symptoms of IIPV?

Baxter has advised patients and caregivers to watch for the potential signs of IIPV. If patients or caregivers notice any of the following symptoms, they should stop the device, initiate manual drain, and contact their healthcare provider immediately: - Difficulty breathing - Vomiting - Child complaining of a “funny feeling” in the abdomen - Child crying during therapy without other apparent reasons - Difficulties feeding - Feeling full and bloated or overfilled after treatment - Abdominal pain or discomfort - Expanded or tense abdomen - Swelling around the genital area (labia, scrotum) - Swelling around the groin region and belly button - Swelling around the tunnel tract of the peritoneal dialysis catheter - Leakage of fluid from the PD catheter exit site - Unexpected increase in blood pressure If you, or someone you love, experienced any of these symptoms while undergoing home kidney dialysis treatments using a Baxter HomeChoice or HomeChice PRO Dialysis Cycler and would like the attorneys at Nolan Law Group to review your potential case, please contact us.

Recall Timeline

January 8, 2010: Baxter Healthcare Corporation initiates voluntary Field Corrective Action of HomeChoice and HomeChoice PRO peritoneal dialysis cyclers due to reports of serious injury and at least one patient death associated with the devices. March 2, 2010: Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. If you, or someone you love, have been injured using a Baxter recalled HomeChoice or HomeChice PRO Dialysis Cycler and would like the attorneys at Nolan Law Group to review your case, please contact us.

Legal Rights

If you or someone you love have been injured from the use of a Baxter recalled HomeChoice or HomeChice PRO Dialysis Cycler you have the right to file a legal claim. Our attoneys can help you determine if you have a case and how to file a claim. All claims are handled on a contingency fee basis, meaning you do not have to pay attorney fees unless you are awarded compensation. If you would like the attorneys at Nolan Law Group to review your case, please contact us.