GranuFlo Dry Acid Concentrate and its sister product, NaturaLyte Liquid Acid Concentrate, are administered to kidney patients during dialysis at clinics in Wisconsin and across the country. They are supposed to replace amino acids that the patient’s body loses while undergoing treatment for acute and chronic renal failure.
GranuFlo and NaturaLyte are used with three-stream hemodialysis machines. They contain a concentration of acetate or sodium diacetate (acetic acid plus acetate). As patients receive infusions of these concentrates, it should raise their serum bicarbonate levels. This helps to establish a proper pH balance.
However, according to the U.S. Food and Drug Administration (FDA), an improper dose of these products can actually raise the serum bicarbonate levels dangerously high. This can then trigger a condition called “metabolic alkalosis.
As a result, a patient may face an elevated risk of experiencing side effects that include:
- Low blood pressure
- Low potassium levels
- Low blood oxygen levels
- Elevated carbon dioxide levels
- Irregular heart beat.
If these side effects are not properly treated, a patient could experience convulsions, heart failure, heart attack, coma or death, the FDA says.
Due to these risks, the FDA issued a Class I recall of GranuFlo and NaturaLyte in March 2012. This is the most serious kind of recall. It is reserved for only those situations in which there is a reasonable probability that use of the recalled product will lead to serious adverse health consequences or death.
Who is Responsible for GranuFlo and NaturaLyte?
Fresenius Medical Care North America manufactured and distributed GranuFlo and NaturaLyte from January 2008 through June 2012.
The New York Times described Fresenius as the nation’s largest operator of dialysis treatment clinics and a leading supplier of dialysis machines and products. Due to Fresenius’ extensive reach, thousands upon thousands of patients may have been exposed to these products’ potential health risks. In Wisconsin alone, more than 60 Fresenius and non-Fresenius clinics may have treated patients with GranuFlo and NaturaLyte.
Although there have been no documented GranuFlo- or NaturaLyte-related deaths, Fresenius sent a memo to its own clinics in November 2011 in which it warned that GranuFlo “appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest,” according to the New York Times. However, according to the Times, the company did not warn non-Fresenius clinics about this risk until the FDA received, anonymously, a copy of the memo and launched an inquiry into it.
Get Legal Help from a Wisconsin GranuFlo / NaturaLyte Injury Lawyer
The recall of GranuFlo and NaturaLyte products will protect future dialysis patients in Wisconsin and across the country. Unfortunately, the recall cannot provide relief to those patients and families who have already suffered harm.
If you are among these victims, Techmeier Law Firm can help you to seek the justice you deserve. We are currently reviewing GranuFlo and NaturaLyte injury claims.
To learn more about your legal rights and options, contact us today. Call (888) 974-0628 or submit our online form. You will not pay for our legal services unless we secure a recovery for you.
- Medical Device Recalls – Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate, U.S. Food and Drug Administration
- “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” New York Times