The FDA has issued a Class 1 recall for several models of Baxter HomeChoice automated dialysis systems because of a defect that can cause the machines to overfill a patient’s abdominal cavity with fluid. Reports of at least one death and several serious injuries have been associated with the problems.
The FDA classified the action as a Class 1 medical device recall, meaning that the defective product has the likely potential of causing serious injury or death.
It has been confirmed that at least one death and several serious injuries have occurred among users of the dialysis machines that overfilled their abdominal cavities, causing a condition known as Increased Intraperitoneal Volume (IIPV).
Dialysis is used to replace kidney function in patients suffering from kidney failure. Peritoneal dialysis machines, like the Baxter HomeChoice and Home Choice Pro devices, pumps a sterile glucose solution into the abdominal cavity around the intestines, which absorbs waste products from the blood through osmosis before being drained out of the body. Peritoneal dialysis is known for its ability to be used at home by patients without assistance.
IIPV can cause a number of problems and potentially fatal injuries, including abdominal wall or diaphragmatic hernias, heart failure, acute hypertension, pulmonary edema, hydrothorax, decreased pulmonary function, pericardial effusion, and peritonitis. Children and non-verbal patients are considered to be most at risk. Children’s abdominal cavities are smaller and can be injured faster by IIPV than an adult, and non-verbal patients and children may not be able to adequately communicate that there is a problem.
According to a Baxter press release, signs of IIPV can include:
* Difficulty breathing
* Feeling full or bloated
* Abdominal pain or discomfort
* Swelling of the genitals, belly button or groin
* Leakage of fluid from the peritoneal dialysis catheter
* Unexpected increase in blood pressure
* Children crying during therapy without apparent reason
The recall affects all Baxter HomeChoice Automated Peritonela Dialysis Systems with the product codes 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D, and 5C4474DR. The recall also affects Baxter HomeChoice PRO Automated Peritoneal Dialysis Systems with the product codes 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300 and T5C8300R. Both systems have been distributed to patients since 1994.
The FDA warned that patients and caregivers should watch for any signs of IIPV. If any signs of IIPV are noticed, the device should be stopped immediately and a manual drain initiated. Then a doctor should be contacted immediately.
More information here: http://www.baxter.com/press_room/press_releases/2010/03_02_10_homechoice.html