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Dialysis System Recall: Baxter Healthcare Faced with Class I Recall
Dialysis Systems by Baxter called HomeChoice and HomeChoice PRO are under a medical device recall following reports from physicians that people have experienced serious injury and one known death because of a defect in the product. The specific defect is unknown at this time. What is known is that the Automated PD system which is programmed to repeatedly deliver and remove dialysis solution may produce increased Intraperitoneal Volume (IIPV). Intraperitoneal Volume (IIPV) is described as overfilling of the abdominal cavity.
Intraperitoneal Volume (IIPV) is known to cause serious breathing difficulty, hernias of the abdomen or diaphragm, pulmonary dysfunction, hypertension, hydrothorax, pericardial effusion and peritonitis. Dialysis patients that are children or are seriously ill are at an increased risk of injury from the affected models of Baxter’s Dialysis System.
Some physicians may still be using Baxter’s HomeChoice and HomeChoice PRO. If they are still using Baxter’s Dialysis Systems, they are being advised by the FDA to inform dialysis patients about the risk associated with HomeChoice and HomeChoice PRO.
Nearly 300,000 people undergo dialysis annually. If you undergo dialysis, it is important to inquire about the safety and efficacy of all medical devices involved in your treatment. Risks and benefits are associated with all medical treatments. In the case of a medical device recall, the risk is elevated more than an acceptable standard defined by the Food and Drug Administration and the law. Such situations include:
- When an alternative design would have prevented the risk.
- When an alternative product is equally effective but not associated with elevated risks.
- When a manufacturer fails to warn the consumer of the risks.
Dialysis victims that have been injured because of the defect in Baxter’s system may be entitled to financial compensation for their injuries. The Baxter dialysis system recall is a Class I Recall, denoting the most serious risk of injury or death.
If you or a loved one has been seriously injured because of Baxter’s HomeChoice or HomeChoicePro, contact Burton Padove for a free consultation at 219-836-2200.