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Fresenius Medical Care

Granuflo Risk textGerman-based Fresenius Medical Care is one of the industry leaders in the production and provision of medical devices and products for the treatment of end-stage renal failure. This company, however, is no stranger to the impacts of product recalls, and has issued several widespread recalls in recent years.

As a leader in the treatment of kidney disease, Fresenius products Granuflo and Naturalyte reach a significant number of patients, resulting in widespread concern over safety and effectiveness. Presently, as many as 400,000 Americans are receiving treatment for kidney disease; with an estimated one-third relying on Fresenius products to safety effectuate the hemodialysis process.

Fresenius Medical Care

Fresenius products are designed to effectuate processes designed to assist failing kidneys in cleansing and purifying the bloodstream. When patients are enduring the effects of end-stage renal failure, their kidneys are no longer able to perform this vital task – necessitating intervention from life support technology. Currently, the two most popular methods of kidney dialysis are known as hemodialysis and peritoneal dialysis – of which Fresenius focuses primarily on hemodialysis products and support. In addition to dozens of ancillary dialysis products, Fresenius manufactures dialysis machines both for home use and for use in one of Fresenius’s nationwide dialysis centers.

Aside from the main dialysis machine, there are several attachment parts and components necessary to complete the dialysis process. The machine attaches to the patient through a catheter which is surgically implanted in preparation for the need to begin hemodialysis. From there, blood is slowly drawn from the body using a dialyzer, cleansed and purified, then cycled back into the body.

In addition to the machine itself, Fresenius also manufactures the following:

  • Granuflo, Nautralyte and Citrasate concentrate mixing tanks;
  • Crit-line monitoring devices;
  • Ancillary devices, including bloodlines, filters, diabetic supplies, and antiseptic products;
  • Optiflux and Hemoflow dialyzers;

Naturalyte and Granuflo recall

Naturalyte and Granuflo, used in conjunction with the Fresenius hemodialysis machines, are concentrates essential to the blood purification process. Naturally, the chemical makeups of these products must be exactly measured and calculated for use in kidney failure patients in order to avoid imbalance or adverse side effects. In 2012, however, Fresenius issued a Class I recall of both its Naturalyte and Granuflo acid concentrates amid rising concerns with the acetate or sodium diacetate levels in these products.

According to multiple patient reports, the acetate and sodium diacetate levels in the Naturalyte and Granuflo products were too high, resulting in unexpectedly high serum bicarbonate levels. When left untreated, this can cause a condition known as metabolic alkalosis – which could quickly result in severe cardiac problems in patients unaware they have been over-treated with these concentrates.

In other words, improper serum bicarbonate levels can cause a disruption in the patient’s pH balance, resulting in either too much base or too much acid.

More specifically, patients experiencing metabolic alkalosis may suffer the following:

  • Mental confusion, which could lead to a stupor or coma;
  • Low blood pressure;
  • Tremors;
  • Light headedness or dizziness;
  • Muscle twitches;
  • Nausea and vomiting;
  • Numbness or tingling in the face, hands or feet;
  • Tetany (chronic muscle spasms)

In addition to the above-described side effects, severe alkalosis can cause cardiac arrhythmia, cardiac arrest, stroke and even death.

Hemodialysis, in and of itself, is not without risk either. Patients enduring daily or weekly dialysis treatments are at an increased risk for leg cramps, fatigue, chest pains, nausea or headache. More serious dialysis effects can include sepsis, bone decay, neuropathy or heart disease.

Legal options following dialysis injury

As with any medical device or product, manufacturers are under a duty to protect patients from an unreasonable risk of harm. Product makers like Fresenius are responsible for properly testing their items on a regular basis to ensure patient safety is always upheld and constantly maintained. In the event a consumer product maker uncovers an issue or safety problem, it is under a duty to promptly warn patients of the issue and, if necessary, remove the products from the stream of commerce. Failure to properly protect consumers from the serious and dire risks associated with a product often leads to significant liability and sizable settlements to injured plaintiffs.

When determining liability in a Granuflo lawsuit, all facts are considered surrounding the events to determine whether the product maker had actual knowledge of the risks – or, at least, should have known of the potential for harm.

For instance, prior to the 2012 recall of the Naturalyte and Granuflo products, the FDA received an anonymous memo that was distributed internally by Fresenius employees indicating its awareness of cardiac arrest deaths in patients treated with these particular concentrates. Nonetheless, the company did not issue a warning to patients or providers about these risks until a formal recall was issued.

  1. The Kidney Fund, Kidney Disease Statistics,
  2. Fresenius Medical Care, Fresenius Products,
  3. National Institutes of Health, Alkalosis
  4., Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate