Class I Recall
IMAGE SOURCE: Baxter International Web site
Baxter International Inc. is facing a Class I recall of its dialysis machine, the most severe safety warning. Class I means there is a potential for death or serious injury.
The medical device manufacturer is supposed to report to the FDA any adverse reports, and Baxter says over the last two years it has received serious injury reports and at least one patient death associated with the dialysis machine.
The medical devices, marketed as HomeChoice and HomeChoice PRO, help patients with severe chronic kidney failure.
The patient died of increased Intraperitoneal Volume (IIPV) which is an overfill of the abdominal cavity. IIPV may also cause an abdominal wall hernia, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion, reports Baxter.
Baxter says it is looking into the problem with the machines and it will develop modifications to software to advise patients at-home as well as include messages and alarms to reduce the risk of fluid accumulation.
Eventually the company will submit a 510 (k) notification to the FDA, later this year when it reintroduces a device onto the market that has some changes or modifications. The machines do not need to be returned and can still be used the company says.
Patients and their caregivers should watch for signs of abdominal overflow such as vomiting, difficulty breathing, a child complaining o a “funny feeling” in their abdomen or crying during therapy, and feeling full, bloated or overfilled after treatment. Patients or caregivers can report any problems to the FDA MedWatch Online Voluntary Form online.
In September 2000, the FDA received a narrative of a failure of a HomeChoice device. Baxter International primarily focuses on kidney disease and hemophilia products. The company was also involved in the H1N1 vaccine.
The dialysis system is a Class II medical device under the FDA criteria. It was submitted for approval under the 510 (k) system.
In 2001, its dialysis machine resulted in several deaths, and in 2008 the company dealt with problems with heparin, the anticoagulant. Two infants died when a Corpus Christi, Texas hospital gave 17 babies an overdose at its neonatal unit which may have been 100 times the prescribed amount.
Actor Dennis Quaid’s 12-day-old twins survived an adult dose of heparin. The adult dosage is 10,000 units with a dark blue label and the 10 unit is light blue for children.
The Quaids sued Baxter International over the labeling issue which they say in their complaint should have been fixed when a similar incident in Indiana killed three infants. Baxter redesigned the heparin labels after the Indiana deaths, but the Quaid twins received heparin from old vials still in hospital storage rooms that were not part of the redesigned label.
As a result of the litigation, Baxter increase size of label by 20 percent and added red warning signs to adult doses. #