Fresenius Fails to Warn about Defective Products That Could Injure or Kill Patients
The largest provider of Dialysis equipment and services in the US has failed to warn patients about life-threatening product defects that could be responsible for an unknown number of deaths and injuries including heart attacks and potentially deadly peritoneal infections known as peritonitis. According to attorney Jeffrey Bowersox, Fresenius has been under investigation by the FDA for failure to issue warnings to patients and failing to recall dangerous products it manufactures and distributes. In the recent cases of three dangerous and defective products, Fresenius only recalled them after being given warnings by the FDA. Now an investigation into intentional wrongdoing by Fresenius is underway. Some of the most important recalls so far are the Liberty Cycler Sets (cassettes), known to leak and cause peritonitis which can be deadly or cause a patient to lose the ability to use peritoneal dialysis, and both of the acid concentrates, also known as dialysates, used in their peritoneal dialysis and hemodialysis brand named GranuFlo® and NaturaLyte®.
Liberty Cycler Sets (Cassettes) Cause Peritonitis Illness, Death
The FDA letter, dated September 15, states that Fresenius has not taken sufficient action to address a faulty product, called a Liberty Cassette, which is a disposable part for home dialysis machines. The FDA said that the company investigated 118 complaints between 2001 and 2009 that the devices leaked, causing six adverse patient reactions and two cases of peritonitis. While the company put a hold on shipping the devices, and ordered a rework of the device in November of 2009, it did not issue a recall, or take other action to reduce patient risk, for devices already on the market.
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GranuFlo® and NaturaLyte® Dialysates increase Heart Attack Risk 6 Times Higher
According to the U.S. Food & Drug Administration (FDA) and Fresenius, GranuFlo® and NaturaLyte® can contribute to elevated bicarbonate levels in patients, leading to hemodialysis metabolic alkalosis, a significant risk factor for a variety of heart and health problems, including:
Sudden Cardiac Arrest
Sudden Heart Attack
Hemodialysis cardiac arrest
Hemodialysis cardiopulmonary arrest
Altered mental status (confusion)
Low blood pressure
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If you or a loved one have been harmed by use of the Fresenius Liberty Cycler, or used Granuflo or Naturalyte Dialysates and suffered cardiac arrest, sudden heart attack, hemodialysis cardiac arrest, hemodialysis cardiopulmonary arrest, stroke, heart arrhythmia or death, please call Jeffrey Bowersox, the Fresenius Dialysis Injury Lawyer for immediate help toll free at 855•269•3776.