Baxter Dialysis Blood Filter

The deaths of more than fifty hemodialysis patients have been linked to the dialysis filter used to remove toxins from their blood. The filters that are responsible are the A-series filters manufactured by Baxter International. Baxter International reported that a fluid used in the manufacturing process was not completely removed from the filters. The fluid, which is liquid at room temperature, turns into a gas at body temperature. This could have left gas bubbles in the patient's bloodstream. Autopsies of some of the patients have found bubbles in the patient's bloodstream. The A-series filters have been withdrawn from the market, and the FDA is investigating whether other dialysis filter manufacturers use the same fluid in their manufacturing processes.

On November 5, 2001, Baxter International released a "Dear Baxter Patient" letter expressing deep sorrow concerning the hemodialysis patient deaths. During the company's exhaustive investigation, a probable cause was discovered that pointed to a fluid used in the manufacturing process of some dialysis filters. Though the company is still conducting confirmatory studies, Baxter felt a responsibility to immediately inform the public. The only filters that are affected are the A, AX, and AF dialysis blood filters. Investigations of the deaths of more than fifty patients that used Baxter dialysis filters are underway. Four of the deaths occurred in the U.S. with the remainder occurring in Europe.

What is Dialysis?

Dialysis is the process of removing waste products and excess water from the body. The two types of dialysis are hemodialysis and peritoneal dialysis.

Hemodialysis filters the toxins out of the blood after some of the patient's blood is removed from the body and pumped through a machine. The purified blood is then returned to the body. This process continued until a large portion of the patient's blood has been purified.

During peritoneal dialysis, a fluid containing a special mixture of glucose and salts is infused into the abdominal cavity. The fluid draws the toxins out of the tissues and is then drained out.

Who needs dialysis?

Patients that have end-stage kidney failure need dialysis.

What diseases cause end-stage renal disease?

• High blood pressure
• Urinary tract obstruction
• Glomerulonephritis (inflammation of specific structures of the kidneys, glomeruli)
• Kidney abnormalities, such as polycystic kidney disease
• Diabetes mellitus
• Autoimmune disorders, such as systemic lupus erythematosus
• Toxic substances
• Allergic reactions
• Blocked arteries or veins within the kidneys
• Crystals, protein, or other substances in the kidneys
• Conditions affecting the nephrons (filtering units of the kidneys)
• Tumor pressing on the urinary tract
• Enlarged prostrate
• Low blood volume (blood loss, dehydration)
• Extremely low blood pressure
• Liver failure
• Heart failure

Was the same fluid used in these filters also used in the  manufacturing of others?

Baxter reported that fewer than 10% of the A-series filters were manufactured using this fluid. Manufacturing of filters with the fluid was reserved for those filters that were set aside because they failed a quality control test. The FDA is investigating whether other filter manufacturers use this fluid.

Why did the fluid cause a problem?

Though the fluid is not supposed to be toxic to humans, the fluid, which is liquid at room temperature, becomes a gas if warmed to body temperature. This could have created gas bubbles in the bloodstream.