Meridian Dialysis : Device Complications

Product Liability:

Meridian Dialysis Device Complications

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The US Food and Drug Administration (FDA) has classified Baxter Healthcare Corporation's September 28 recall of the Meridian Hemodialysis Instruments as a class 1 recall. This is a designation that is given to products that could cause serious harm or death.

According to the FDA alert sent today from MedWatch on December 14th, 2005, the action was based on reports of hemolysis related to kinking of blood tubing sets routed through both channel clips on the front of the device. The return of hemolyzed blood to a patient can result in serious and potentially fatal adverse events.

What is the Meridian Dialysis Device?

The Meridian Dialysis Device is a kidney dialysis machine that performs hemodialysis. Hemodialysis is a method for removing waste such as urea from the blood when the kidneys are incapable of this (i.e. in renal failure). It works by having the blood flow along one side of a semipermeable membrane, with the dialysis solution flowing along the other side, usually in the opposite direction. A prescription for dialysis by a renal physician will specify various parameters for setting up dialysis machines, times and durations of dialysis sessions.

Dialysis Overview

Dialysis is the movement of molecules in the blood by diffusion from high concentrations to low concentrations through a semi-permeable membrane. The goal of dialysis is to get the molecules to reach a state of equilibrium. Dialysis is most commonly prescribed for patients with temporary or permanent kidney failure.

Dialysis treatment replaces the function of the kidneys, which normally serve as the body's natural filtration system. Through the use of a blood filter and a chemical solution known as dialysate, the treatment removes waste products and excess fluids from the bloodstream, while maintaining the proper chemical balance of the blood.

There are two types of dialysis treatment: hemodialysis and peritoneal dialysis. Hemodialysis is the most frequently prescribed type of dialysis treatment in the United States . The treatment involves circulating the patient's blood outside of the body through a dialysis circuit, such as the Meridian dialysis device. Two needles are inserted into the patient's vein, or access site, and are attached to the device, which consists of plastic blood tubing filter known as a dialyzer, or an artificial kidney, and a dialysis machine that monitors and maintains blood flow and administers dialysate, a chemical bath that is used to draw waste products out of the blood.

To contact an attorney about a serious injury or death related to a Meridian dialysis device, use the form below for a free case evaluation.

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