Tagged Articles

inadequate labeling 4 articles

Researchers study abnormal heart rhythm, sudden cardiac death among dialysis patients

A group of researchers from the University of Cincinnati is hoping that an implantable device can identify undetected heart rhythm abnormalities in patients undergoing hemodialysis. These patients are at high risk for sudden cardiac death, which doctors say may be linked to large shifts in electrolytes and volume in the blood during regular dialysis sessions. The study could help establish a link between heart rhythm abnormalities and different electrolyte levels in patients’ blood and in the solution used during dialysis. People with end-stage renal disease rely on dialysis to replace kidney function. The process involves a machine that filters waste ... Read More

Study: Fresenius blood volume product increases risk of death in critically ill patients

A product made by Fresenius and B. Braun Holding to increase blood volume in critically ill patients increases the risk of death and kidney damage and should no longer be used, a researcher with the London School of Hygiene and Tropical Medicine recommended. Hydroxyethyl starch solution, also known as colloid fluid or crystalloid fluid, is used to stabilize patients with low blood pressure caused by conditions such as dehydration, blood loss, shock, and organ damage from blood infections. Hydroxyethyl starch is widely used in Europe, the UK and Canada, but not as popular in the U.S. An alternative fluid for ... Read More

Wrongful death lawsuits filed against world’s largest dialysis provider

Fresenius Medical Care, the world’s largest provider of dialysis products and services, says it believes wrongful death lawsuits waged against the company are without merit and it intends to defend them vigorously. A group of plaintiffs last month filed a petition to form a federal multidistrict litigation (MDL) and consolidate lawsuits against the company alleging that inadequate labeling and warnings for Fresenius dialysate concentrate products NaturaLyte and GranuFlo caused harm to patients. “We have commented many times on our pride in our global team’s commitment to quality. One has to understand that nature of the medical status that influences the ... Read More

Plaintiffs file petition for MDL against Fresenius in wrongful deaths of dialysis patients

A group of plaintiffs have filed a petition to form a federal multidistrict litigation (MDL) against Fresenius Medical Care Holdings, Inc. and its subsidiaries, for the wrongful deaths of dialysis patients who received toxic amounts of a dialysate concentrate that caused them to suffer cardiac arrest. The MDL was filed in the United States District Court for the District of Massachusetts, and allege generally that inadequate labeling and warnings for Fresenius’ dry acid concentrates GranuFlo and NaturaLyte caused harm to patients. Fresenius contends that the lawsuits are without merit, and the company says that it will defend them vigorously. In ... Read More