Fresenius Medical Care North America (FMCNA) is the world’s leader in dialysis healthcare. Combining innovative products such as state-of-the-art dialysis machines, dialyzers, and pharmaceuticals, Fresenius Medical Care North America (FMCNA) estimates they serve more than160,000 patients and their families each year.
Fresenius Medical Care North America (FMCNA) is the largest provider of renal care products and services in the nation. They employ over 45,000 employees in North America, employees whose primary purpose is to improve the lives of individuals living with renal disease. According to the company, they do not want to simply provide products, but they also want to create connections with patients and their families through “caring treatment, guidance and comfort.”
Fresenius Medical Care group specializes in hemodialysis, acute dialysis, peritoneal dialysis, dialysis care, liver support therapy, and therapeutical apheresis. Other entities include Fresenius Kabi, which specializes in clinical nutrition (parenteral and enteral) and transfusion technology; Fresenius Helios, which includes the Helios Kliniken Group; and Fresenius Vamed, which specializes in hospital services.
Fresenius Medical Care North America (FMCNA) is a large conglomerate, but its humble beginnings started in one of Frankfurts oldest pharmacies, the Hirsch Apotheke. This business was bought by the Fresenius family in 1911. Soon after Dr. Eduard Fresenius established a pharmaceutical company and began creating products. Dr. Fresenius worked with the Frankfurt University Medical School to develop a variety of medicinal products, including his first product Bormelin, a nasal ointment. Like many German companies, the company struggled during World War II. With the death of Dr. Eduard Fresenius, new leadership was provided by Else Fernau. She, along with her husband, lawyer Hans Krӧner, began to develop new pharmaceuticals, including an infusion solution used in surgery and other solutions for nutritional benefits. By 1966, the company shifted their focus to helping patients with chronic kidney disease, including the eventual designing, manufacturing, and selling of its own dialysis machines. Through growth, mergers, and acquisitions, the company has expanded to several major countries including Germany, Austria, Sweden, the United Kingdom, China, Norway, Canada, France, Italy, Belgium, the United States, Poland, Switzerland, India, the Netherlands, South Korea, and Brazil. The company now provides hemodialysis, home dialysis, and transplant support services to thousands of patients. They are also a major Pharmaceutical manufacturer, they manufacturer surgical and medical instruments, and they manage service centers around the world to help patients with renal disease.
Granuflo, which is prescribed as an additive and is used in conjunction with the hemodialysis machine and dialyzer during kidney dialysis, is a dialysate, which is a dry acid product containing sodium diacetate. Granuflo is manufactured by Fresenius Medical Care, the largest provider of dialysis services and products in the world. Introduced by Fresenius in 2003, there have been a number of complaints that this additive may steadily increase a patient’s serum pre-dialysis bicarbonate levels. When the rise is not regulated and the amount of additive decreased as needed, patients may face a significantly greater risk of cardiopulmonary arrest and sudden cardiac death in the dialysis clinic. Granuflo is regulated by the FDA. In the last several years the FDA has received complaints from claimants who have suffered injury from the use of Granuflo. Specifically, claimants allege Fresenius Medical Care may have manufactured and sold Granuflo with insufficient warnings and instructions for its safe use.
On June 25, 2012, the Federal Drug Administration (FDA) issued a Class I Recall for a Fresenius GranuFlo (powder) Acid, which was manufactured and distributed from January 2008 through June 2012. Granuflo is an additive used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates. The FDA claims, however, there is a risk of alkalosis with acetate containing dialysis acid concentrates. Granuflo uses acetic acid and sodium acetate, which can increase the amount of sodium acetate in the dialysate, leading to too much bicarbonate in the patient’s blood. Too much bicarbonate can increase the risk of cardiac arrest, cardiopulmonary arrest, metabolic alkalosis, stroke, low blood pressure, and death.