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sudden cardiac death 37 articles

Study focuses on reducing sudden cardiac death in dialysis patients

Patients with end-stage kidney disease are at high risk of sudden cardiac death when they begin dialysis treatment. A team of researchers with the University of Rochester Medical Center are conducting the largest clinical study of its kind focused on reducing sudden death in dialysis patients. Sudden cardiac death is the single largest cause of death in dialysis patients, occurring in about a quarter of dialysis patients. It is defined by a sudden and unexpected death caused by loss of heart function. Dialysis is a treatment that filters the blood to rid the body of harmful waste and extra salt ... 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

World Kidney Day raises awareness of kidney disease worldwide

World Kidney Day, a campaign designed to raise awareness of the importance of kidneys to overall health and to reduce the frequency and impact of kidney disease and its associated health problems worldwide, was held March 13, 2014. Chronic kidney disease is a growing problem and costs to treat the condition pose an enormous burden on health care systems around the globe. About one in 10 people have some form of kidney damage, and every year millions die prematurely from complications related to kidney disease. Many patients who develop late-stage kidney disease will require dialysis treatment to filter the blood ... Read More

Fresenius recalls defective dialysis machines

Fresenius Medical Care is recalling more than 111,000 hemodialysis machines sold throughout the United States, Canada and Mexico. The recall, which affects specific model numbers from the Fresenius 2008 Series hemodialysis machines, was issued due to complaints of the saline bags inappropriately filling during recirculation and setup. Dialysis machines are designed to cleanse and filter the blood of patients with kidney disease whose kidneys do not function properly. Nearly 400,000 people in the United States undergo this life-saving treatment every day. Fresenius is the world’s largest provider of dialysis products and services, providing dialysis treatments within its own facilities and ... 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 urges dialysis patients to get flu shots despite mounting GranuFlo lawsuits

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is strongly encouraging dialysis patients to get a flu shot. The company is even offering free flu vaccinations to all of its dialysis patients and employees, a generous offer considering the company’s poor track record with communicating important health issues to patients and staff. The company is currently facing numerous wrongful death, personal injury and false advertising lawsuits stemming from its dialysis concentrates GranuFlo and NaturaLyte. The products are used to help balance electrolytes in the blood during dialysis. One of the ingredients in the solutions converts to ... 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

Dialysis patients seeing nephrologists with larger caseloads at greater risk of dying

Patients receiving dialysis treatments from physicians with greater caseloads are more likely to die than patients of less-busy nephrologists, according to a new study published in the Journal of the American Society of Nephrology. Researchers noted that patients’ death risk increased 2 percent for every increase of 50 patients per nephrologist. The study was the first to examine mortality risk in hemodialysis patients based on physician caseload. The study involved 7,600 adults treated by 341 physicians at select DaVita dialysis facilities who underwent hemodialysis for at least 20 consecutive quarters from July 1, 2001, to June 30, 2006. Follow-up was ... Read More

Another wrongful death lawsuit filed against Fresenius GranuFlo, NaturaLyte

A wrongful death lawsuit against Fresenius Medical Care involving two of its dialysis products has been removed to federal court. In the lawsuit, Phillip Harris alleges that Fresenius, the world’s largest provider of dialysis products and services, failed to adequately warn, train, instruct and monitor treating physicians and health care facilities to ensure that their products were being properly administered, and as a result his wife Shirley Harris died from injuries sustained after being administered Fresenius products GranuFlo and NaturaLyte. The lawsuit claims that the dialysis products were improperly labeled, which resulted in patients, including Shirley, suffering from significant health ... Read More

Another wrongful death lawsuit filed against Fresenius related to dialysis product

Another wrongful death lawsuit has been filed against Fresenius Medical Care, the world’s largest provider of dialysis products and services. The lawsuit alleges that a woman died after using two products created by the company during her dialysis treatment. Shirley Harris underwent dialysis treatment during which she received GranuFlo and NaturaLyte, two dialysate products made by Fresenius. The lawsuit alleges the products were improperly labeled, which caused her and other patients to experience significant health problems including heart attack, cardiopulmonary arrest, stroke, and/or sudden cardiac death. The lawsuit was filed by Shirley’s husband, Phillip, who claims the company failed to ... Read More