What is the GranuFlo Dry Acid Concentrate?
Dialysis is the process of artificially filtering the blood of patients suffering from chronic kidney disease, renal failure, or other problems related to their kidney function. In hemodialysis, the patient’s blood is pumped through a dialyzer and treated with a chemical component to make sure all of the impurities are filtered out of the blood before reentering the bloodstream. GranuFlo is a dry acid concentrate used in dialysis procedures.
What are the potentially fatal risks connected to GranuFlo?
Unlike the ingredients used in traditional liquid acid concentrates, the acetic acid and acetate used in GranuFlo metabolizes into bicarbonate at much greater rates, increasing the risk for metabolic alkalosis.
What are some of the health complications related to metabolic alkalosis?
Metabolic alkalosis is a condition in which the pH resulting from increased bicarbonate concentrations. Patients who develop this condition are at much higher risk for:
- Low blood pressure
- Cardiac arrhythmia
- Cardiopulmonary arrest
- Sudden heart arrest
- Heart attack
What is a Class I recall and why were the Fresenius products recalled labeled as Class I?
The FDA reserves class I recalls for products that could foreseeably cause serious health complications or death. Patients with renal problems undergo dialysis approximately five times a week, if consistently exposed to unnaturally high levels of bicarbonate, patients can reasonably expected to develop serious conditions.
Why is Fresenius Medical Care under investigation for its product GranuFlo?
Fresenius Medical is the nation’s largest operator of dialysis centers, and the manufacturer of the dry acid concentrates GranuFlo and NaturaLyte Acid Concentrates. In June of 2012, the FDA opened an investigation to determine whether the company violated federal regulations, and failed to inform customers of the potentially fatal risks involved with the use of their products. Although the company released an internal memo warning doctors at Fresenius dialysis centers of the potential for risk of GranuFlo patients dying from sudden cardiac arrest, the company did not issue a public notice until March of 2012 after being prompted by the FDA.
I’ve suffered developed health complications that may be related to my regular dialysis treatments. What can I do?
The most important thing to do is to contact your healthcare provider to determine what products were used during your dialysis procedures. If your complications may be linked to the GranuFlo or NaturaLyte products, consult a professional attorney regarding your potential case. The FDA has received numerous reports linking alkali dosing errors for hemodialysis patients treated with the dialysate concentrates containing acetic acid and acetate, prompting a Class I recall for GranuFlo and NaturaLyte.
What can a defective medical device lawyer do?
GranuFlo and NaturaLyte are the most widely used dry acid products in the United States, with approximately 125,000 patients receiving treatment with GranuFlo. The defects associated with the Fresenius products could potentially cause injury or death to thousands of patients, a risk the company neglected to mitigate by failing to warn doctors at all dialysis centers of the dangers associated with the products. A professional Fresenius dialysis injury lawyer can help injured patients file a product liability claim and recover financial compensation for the damages incurred.