Tagged Articles

dialysis services 15 articles

Fresenius may open new dialysis clinic in Louisiana despite AG’s lawsuit

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is proposing to build a new dialysis center in Terrytown, La., despite being slapped with a lawsuit by the state’s Attorney General earlier this month. Fresenius owns nearly 100 dialysis clinics in Louisiana. The company uses its brand-name products in its facilities and also sells them to non-Fresenius-owned clinics. The state’s lawsuit claims that Fresenius’s dialysis concentrates GranuFlo and NaturaLyte caused patients to suffer from injuries including sudden cardiac arrest, and that the company violated Louisiana law and attempted to defraud dialysis clinics, physicians, the state and its residents by ... Read More

Injuries, death linked to recalled NaturaLyte dialysis concentrate

Fresenius Medical Care, the world’s largest provider of dialysis products and services, has received one report of death and two injuries linked to recalled lots of NaturaLyte liquid bicarbonate concentrate. The recall was initiated after testing revealed that certain lots of NaturaLyte had elevated levels of a bacteria identified as Halmonas, a Gram Negative bacteria typically found in water with high salinity. Bacterial contamination of dialysate could cause bacteremia or systemic infection. Fresenius issued a recall of 49 lots in on April 4, followed by a second recall of nine additional lots on May 1. At that time, Fresenius said that ... Read More

Fresenius issues second recall of NaturaLyte due to bacterial contamination

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is recalling 56 lots of NaturaLyte Liquid Bicarbonate Concentrate, which is used in hemodialysis machines, because the dialysis concentrate may be contaminated with bacteria, which could lead to bacteremia or systemic infection in patients treated with affect products. Fresenius says that the dialysis filter, called a dialyzer, and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that reduces the likelihood of adverse events from occurring. The announcement follows a recall of 49 lots of NaturaLyte due to high levels of bacterial contamination ... Read More

Fresenius recalls 49 lots of NaturaLyte due to bacterial contamination

Fresenius Medical Care, the world’s largest distributor of dialysis products and services, is issuing an urgent medical device recall on 49 lots of NaturaLyte Liquid Bicarbonate Concentrate due to high levels of bacterial contamination found in the product. The company says it is currently conducting an investigation to identify the organism(s) in its dialysis concentrate and, when testing is complete, will announce the identity of those bacteria. NaturaLyte is used to regulate electrolytes in patients undergoing dialysis treatment. The company says no pyrogenic reactions, bacterial infections or related adverse events have been reported to date in connection with the recall. ... Read More

Recent actions call into question whether Fresenius cares about patient safety

Recent actions by Fresenius Medical Care suggest the world’s largest provider of dialysis products and services may not be too concerned about patient safety. One example is the case of Robert Hiller. In January, he filed a lawsuit against Fresenius alleging he was wrongfully fired for simply doing his job of putting “into effect the company’s manufacturing practices to ensure that they were safe and complied with federal and state laws.” He alleged that in 2010 he first raised concerns whether certain practices where harming the purity of some of the products, but Fresenius officials initially dismissed his concerns. He was ... Read More

Two more GranuFlo lawsuits filed against dialysis giant Fresenius

Two new lawsuits have been filed against Fresenius Medical Care North America, joining more than 300 lawsuits that allege two of the company’s dialysis products caused patients to suffer deadly heart attacks. Fresenius, the world’s largest provider of dialysis services and products, manufactures GranuFlo and NaturaLyte, concentrates that are administered to patients prior to dialysis to balance electrolytes. The products are used both in Fresenius facilities as well as dialysis clinics owned by competitor companies. GranuFlo and NaturaLye contain an ingredient that metabolizes into bicarbonate. However, these products contain more of the ingredient than competitor brands. In March 2012, the ... Read More

Fresenius to open dialysis clinic in McCalla, Ala.

Fresenius Medical Care, the world’s largest provider of dialysis services and products, will open a dialysis clinic in McCalla, Ala. The facility is expected to be be in operation by May or June 2014. The property, located near McAdory High School, was purchased by Southeast Medical McCalla LLC. Construction on a one-story medical office building is expected to start sometime in October. Fresenius operates dialysis clinics throughout the country and provides dialysis products, such as dialysis concentrates GranuFlo and NaturaLyte, for both Fresenius-owned and non-Fresenius clinics. The company is facing numerous wrongful death, personal injury and false advertising lawsuits involving ... Read More

Fresenius faces possible class action lawsuit over GranuFlo injuries, deaths

A proposed class action lawsuit has been filed against Fresenius USA Inc., alleging the company knowingly withheld information about serious health risks and deaths associated with its dialysis product GranuFlo. Fresenius USA, is a part of Fresenius Medical Care, the world’s largest provider of dialysis products and services. Dialysis is a process used in people with kidney failure to cleanse the blood of toxins. GranuFlo is a product used during dialysis. Fresenius uses this product in its dialysis clinics and also sells it to facilities not owned by Fresenius. GranuFlo contains a substance that converts to bicarbonate in the blood. ... Read More

Fresenius faces more than 300 wrongful death, injury lawsuits involving GranuFlo, NaturaLyte

More than 300 wrongful death and personal injury lawsuits have been filed against Fresenius Medical Care, the world’s largest provider of dialysis products and services, alleging the company did not adequately warn patients or medical centers about the risk of sudden cardiac arrest with its dialysis products GranuFlo and NaturaLyte. GranuFlo and NaturaLyte are used during dialysis to remove impurities from the blood. Fresenius, which makes the products, uses them in its own dialysis centers as well as distributes them to other dialysis clinics across the country. GranuFlo uses a formulation that the plaintiffs allege causes an unsafe elevation of ... Read More

Granuflo manufacturer Fresenius receives third FDA warning letter this year

The Food and Drug Administration (FDA) has issued a warning letter to Fresenius Kabi AG regarding problems with product labeling and responses to complaints at its Puerto Rico manufacturing plant. It is the third issue involving the FDA to come to light this year. Fresenius Kabi is one of four segments of Fresenius Medical Care, the world’s largest provider of dialysis products and services. The warning letter concerned the production of blood transfusion bags produced by subsidiary Fenwal Inc. During an investigation in April, FDA investigators found violations in how the company handled complaints, labeling issues, and filing of field ... Read More