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GranuFlo and NaturaLyte are brand names of dialysates manufactured by Fresenius Medical Care - the world's largest provider of kidney dialysis services and products.
On March 29, 2012, after investigating the harmful effects of these products, the Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte to revise prescribing instructions. According to the recall, use of these two products can lead to low blood pressure and cardiac arrhythmia. These condition "may culminate in cardiopulmonary arrest" or other conditions, including death.
Evidence presented that Fresenius was aware of the dangers of these drugs and did not share this information with health care providers or consumers. An internal company memo from Nov. 4, 2011, reported that more than 900 patients had experienced heart attacks in Fresenius clinics during the previous year. The memo states that the company's medical staff reached the conclusion that patients with excessive levels of bicarbonate in their blood were six times more likely to have cardiac arrest than those with normal levels. The memo also linked GranuFlo use to increased bicarbonate levels and heart attacks.
Side effects faced by patients: Hypoxemia or low levels of blood oxygen, Hypokalemia or low levels of blood potassium, Hypercapnia or high levels of blood carbon dioxide, Metabolic Alkalosis, Sudden cardiac arrest, Death
Evidence to be looked for in potential cases:
Granuflo and NaturaLyte Usage in patients before 2012
Evidence of increased bicarbonate levels
Cause of Death as Cardiac Arrest, if death occurrence
Details of Dialysis Facility
Medical Record Review and claim validation of GranuFlo case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.