Baxter HomeChoice | HomeChoice PRO Dialysis Recall

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.