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GranuFlo Manufacturer Fresenius Receives FDA Warning Letter

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After the FDA announced a Class I recall of dialysis products GranuFlo and NaturaLyte in June 2012, Fresenius Medical Care became associated with health care concerns around the country, particularly sudden heart attack and death.

Now, the company is in the news again. On March 5, 2013, the FDA sent the company a warning letter concerning another dialysis product, stating that the validation process was incomplete.

Fresenius Warned About Dialyzers

The warning letter concerned the FDA’s inspection of Fresenius’ Ogden, Utah manufacturing plant. Fresenius produces the Optiflux Polysulfone Dialyzers there, which are so-called “artificial kidneys.” During hemodialysis—a procedure in which the kidney patient’s blood is run through a machine to clean it of waste and toxins—the blood is filtered through a man-made membrane called a dialyzer, and then returned to the body.

According to Fresenius’ own website, the Optiflux Dialyzers are the number-one prescribed dialyzer brand in the U.S., because they’re highly biocompatible, and may reduce inflammation and help prevent the development of long-term dialysis-related complications.

The FDA stated that their investigation “revealed that these devices are adulterated,” meaning that they are impure or inferior, and that the “facilities or controls used for their manufacturer, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements….”

No Recall of the Products

More specifically, the FDA stated that Fresenius had “failed to maintain adequate procedures for verifying the device design.” The company has stated its willingness to work with the agency to resolve the concerns:

“Fresenius Medical Care North America North America is committed to working with the FDA to resolve the concerns stated in the letter,” said Rice Powell, CEO of the company. “We will address the FDA’s observations as soon as possible. We do not expect any effects on the company’s guidance in terms of revenue and earnings in 2013.”

Fresenius Warns Medical Centers Too Late for Some

Last year about this time, the healthcare world was buzzing with the news about the dosing errors that had occurred with GranuFlo and NaturaLyte. Concentrate products used to control acid buildup during dialysis, these products were made with different ingredients than comparable products, and many doctors and technicians were unaware of the change. As a result, some allegedly gave their patients too much, which resulted in high levels of bicarbonate in the blood.

High bicarbonate levels can lead to blood that is too alkaline (rather than too acidic), which can result in low blood pressure, low blood oxygen, heart rhythm problems, and sudden cardiopulmonary arrest. On March 29, 2012, Fresenius issued a memo warning medical centers of the risk, but that was several months after they warned their own dialysis centers of the same risk.

Plaintiffs filing lawsuits against the company for GranuFlo and NaturaLyte injuries claim that Fresenius should have warned all medical centers using the products about the health risks much sooner than they did, and should have included more visible warnings about the correct dosage on the products themselves. In March 2013, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal GranuFlo and NaturaLyte lawsuits into one court in the District of Massachusetts.