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In June 2012, the FDA warned doctors and patients about the potential dangers of GranuFlo and NaturaLyte, two concentrate products used during dialysis procedures to reduce acid buildup in the blood. They stated that these products could have serious adverse health consequences, including death, and issued a Class 1 recall for both.

Fresenius Medical Care, the manufacturer of these products, is now facing hundreds of lawsuits filed by patients claiming to have suffered serious injuries during dialysis procedures with these products. Now, according to a recent article in “Nephrology News,” The FDA has issued a Class II recall of several models of the Fresenius 2008 series hemodialysis machines, due to complaints of saline bags inappropriately filling during recirculation and setup.

Machines May be Malfunctioning

According to the FDA, these machines are used for hemodialysis procedures in hospitals, dialysis centers, and in patients’ homes, for patients suffering chronic or acute renal failure.

A year ago, the news focused on dialysis concentrates GranuFlo and NaturaLyte, and how the incorrect dosage could make a patients’ blood too alkaline and potentially cause symptoms like arrhythmia, low blood oxygen, low potassium, and cardiopulmonary arrest. Now, it’s the machine itself that is in question.

The company notified customers in November 2013 that it had received reports of the saline bag filling inappropriately during dialysis procedures. According to the letter they sent out, they were aware of no deaths or other serious injuries related to this problem. Their action is considered a Class II recall, but no machines are being pulled from the market—customers are simply being notified of the issue, which could affect over 11,000 machines.

GranuFlo Lawsuits Continue

Fresenius maintains that these machines are safe, and has told customers to be sure the machine is installed correctly. They are in the process of updating the labeling.

Meanwhile, the most recent case list from the GranuFlo MDL, which was established in March 2013, shows over 400 GranuFlo lawsuits currently pending in the U.S. District Court, District of Massachusetts. Plaintiffs claim that they experienced serious side effects after going through dialysis where GranuFlo and NaturaLyte were used.

It was in a November 2011 memo that Fresenius Medical Care first warned doctors and other healthcare personnel in their own dialysis centers of the potential problems with these concentrates. The company had conducted a study on over 900 patients who died of a heart attack in their centers in 2010, and found that high levels of bicarbonate in the blood was an independent risk factor for serious complications, such as heart attacks. They noted that GranuFlo was a more concentrated product than previous options, and that doctors needed to be careful not to administer too much. A high dose of the concentrate could result in high levels of bicarbonate in the blood, potentially increasing risk of heart problems.

It wasn’t until the FDA started investigating, however, that the company released another memo to outside medical centers and nursing homes, warning them of the potential issues. Plaintiffs claim hundreds of patients were at risk of serious health issues and death because Fresenius waited too long to warn all facilities that were using the concentrates.

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