At the National Kidney Foundation’s 2011 Spring Clinical Meetings, panelists presented the results from retrospective evaluations of 50 hemodialysis patients hospitalized in October 2010 who had received GranuFlo and/or NaturaLyte. The report said 54 percent of the patients had a serum bicarbonate level that was above the level indicative of metabolic alkalosis.
Fresenius Medical Care North America (FMC), the manufacturer of GranuFlo and NaturaLyte, alerted physicians and medical directors of the firm’s dialysis clinics in a November
2011 internal memo that GranuFlo “appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest,” according to the New York Times.
The same day the FDA issued its recall notice, FMC sent an “Urgent Product Notification” to its clinics and customers. The notice said that analyses of the company’s data about hemodialysis patients using NaturaLyte and GranuFlo “confirms that alkalosis is a significant risk factor associated with cardiopulmonary arrest in the dialysis unit.”