June 4, 2014 — The U.S. Food and Drug Administration (FDA) says it has received one report of death and two reports of injury linked to Naturalyte, a liquid bicarbonate concentrate used in dialysis, that was recalled in April.
On May 1, the FDA expanded the recall to include 9 lots of Naturalyte, in addition to the 49 lots that were recalled on April 10. On May 28, the FDA updated the recall again with reports of injury and death. The recall was also classified as Class I. Click here to read more.
The product was recalled because it can develop high bacteria levels during it shelf life. Laboratory analysis identified the bacteria as Halomonas (species 1, 2, 3), a gram negative bacteria typically found in water with high salt concentration.
The FDA is concerned that patients who receive contaminated Naturalyte could suffer serious adverse health consequences, including sepsis, bacteremia (blood poisoning), systemic infection, and death. Patients who are exposed to significant amounts of endotoxins in bacteria can also develop complications like fever, low blood pressure, flushing, chills, and/or breathing problems.
In 2012, Naturalyte was recalled after it was linked to hundreds of cardiac arrests in patients who underwent dialysis at Fresenius clinics in 2010. When the FDA recalled Naturalyte, they warned that inappropriate dosages could result in a dangerous elevation of bicarbonate in a patient’s blood, which could lead to a condition called metabolic alkalosis. This increases the risk of deadly cardiovascular events, including heart attack, stroke, or death.
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