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Baxter HomeChoice | HomeChoice PRO Dialysis Recall


Defective Medical Device Lawyers Helping Those Harmed by Recalled Baxter HomeChoice PRO Dialysis Systems


People with kidney problems of many types need the help of kidney dialysis machines and systems to help them keep their kidneys functioning properly. These machines protect patients from the harm that would result if the toxins removed by the kidneys were allowed to travel through the body. While the kidney dialysis machine was a remarkable step forward for those who suffered from these problems, the use of these machines is not done without risks.


Unfortunately, these risks were realized for many people recently who were using certain Baxter HomeChoice PRO Dialysis systems that have been recalled. Below you’ll find information regarding the reason these products have been recalled, the specific models that have been recalled, the symptoms to watch for with those who have used these products and finally how you should proceed if you or someone you love has been harmed as a result of using a recalled Baxter HomeChoice PRO Dialysis system.


The Baxter HomeChoice PRO Dialysis Recall – A Brief Overview


Dialysis machines basically pump fluid in and out of a kidney patient’s body, removing the toxins that are present and replacing these tainted fluids with safe materials. The process is somewhat complicated, and when something goes wrong it can be difficult to immediately realize the problem.


The reason that several Baxter HomeChoice PRO Dialysis systems were recalled was that reports were growing in regards to the development of a condition known as Increased Intraperitoneal Volume (IIPV). This condition is basically known as the overfilling of the abdominal cavity. Specifically, there were several reports of serious injuries and one death after using one of these recalled products, and the consequences of IIPV can include:


  • Abdominal wall and/or diaphragmatic hernias
  • Hydrothorax
  • Heart failure
  • Acute hypertension
  • Pulmonary edema
  • Decreased pulmonary function
  • Pericardial effusion
  • Peritonitis 

Specifically, the models that have been recalled include:

 

HomeChoice Product Codes:


  • 5C4471
  • 5C4471R
  • 5C4474
  • 5C4474R
  • T5C4441
  • T5C4441R
  • 5C4474D
  • 5C4474DR


HomeChoice Pro Product Codes


  • 5C8310
  • 5C8310R
  • R5C8320
  • R5C8320R
  • T5C8300
  • T5C8300R 

Symptoms of IIPV


The United States Food and Drug Administration (FDA) has warned anyone who experiences the following symptoms during the dialysis process to discontinue use of the device, to start a manual drain and to seek immediate medical attention:


  • Difficulty breathing
  • Unexpected hypertension
  • Difficulties feeding
  • Abdominal pain
  • Expanded or tense abdomen
  • Vomiting
  • Localized swelling of the area near the tunnel of the catheter or catheter site
  • Fluid leak from the catheter exit site
  • Full, bloated, or overfilled feeling after treatment 

Other Considerations and Warnings Regarding the Baxter Dialysis Recall


As is typically the case when a defective medical device is recalled, there are other dangers that have been explained by the FDA that should be kept in mind. For instance, many patients who need the help of these machines are either children or otherwise unable to clearly communicate. Clearly, this means that if something is wrong, the patient will not be able to warn anyone that there is a problem.


In addition, it should be noted that Baxter has initiated this Class I recall. A Class I recall is the most serious type within the parlance of the FDA, and it means that the product that’s being recalled presents immediate and grave dangers to anyone who has been or is using it. The growing number of reports of serious injuries likely prompted this classification.


Finally, the FDA has not outwardly ordered medical professionals to stop using these products. Instead, it advised individual doctors and medical care providers to make their own judgments on a case-by-case basis as to whether the machine should be removed from use and returned to Baxter in accordance with the manufacturer’s recommendations.


Why You Need a Defective Medical Device Lawyer


Any litigation that results from harm done by a defective medical device is extremely complicated. Not only will the injured plaintiff have to prove that he or she used the machine properly, that the machine was defective and why it was defective, but also that this defect led to the injuries suffered either directly or indirectly.


This form of proof can require the help of expert witnesses who need to explain these highly technical features and defects in a manner that someone without this technical background can understand. This also makes it easier for the defense to confuse and muddy the issue, particularly when dealing with a plaintiff who already suffered from kidney problems.


If you or someone you love has suffered from the effects of using a defective Baxter HomeChoice PRO dialysis system, you need to contact Privett Law immediately to schedule a free initial consultation.