Fresenius indicates that more than 115,000 hemodialysis machines may experience problems where the saline bags fill at inappropriate times, which the FDA has classified as a Class II Medical Device Recall.
The Fresenius recall was announced by the FDA last week, impracting the 2008 Series dialysis machine. The manufacturer notified customers of the potential problems in a November 2013 letter.
According to the product notification letter (PDF) issued by Fresenius Medical Care, dialysate was being pushed into the saline bag during recirculation if the saline line was left unclamped. This was caused by occlusions of the dialysis machine’s drain line in combination with a filling program.
The Fresenius dialysis machine problems have not been linked to any reports of serious injuries or deaths, according to the manufacturer, and the FDA has categorized the action as a Class II recall, suggesting use of the device may cause temporary or medically reversible health consequences.
The recall impacts the Fresenius 2008 Series Hemodialysis Machines with model numbers 2008H, 2008K, 2008K2, 2008k@Home, and 2008T. According to the FDA, 111,504 units were sold in the U.S., and 3,638 units were sold in Canada and Mexico. The machines are used for acute and chronic dialysis therapy of patients with acute or chronic kidney failure. Most are used at dialysis centers, but some of the models were designed for use at home.
Customers with affected machines who have questions can call Fresenius’s technical services hotline at (800) 227-2572.
Fresenius GranuFlo and NaturaLyte Problems
The recall comes as Fresenius faces an increasing number of dialysis treatment lawsuits over its GranuFlo and NaturaLyte products, which were recalled in 2012 amid reports that a higher-than-expected number of patients were suffering sudden cardiac arrest or death during or shortly after hemodialysis treatments where the acid concentrates were used.
Fresenius Medical Care is the largest provider of dialysis services in the U.S., not only manufacturing many of the products and machines used at dialysis centers throughout the United States, but also owning and operating thousands of individual dialysis clinics itself.
NaturaLyte and Granuflo are liquid acid and dry acid concetrates that contain sodium acetate that converts to bicarbonate at higher-than-expected levels. According to allegations raised in the lawsuits, Fresenius knew about these problems, but the company failed to provide adequate warnings or information for physicians about the risk and the importance of monitoring bicarbonate levels during treatment.
In November 2011, Fresenius conducted an internal review involving the use of Granuflo and NaturaLyte at their own clinics, identifying at least 941 instances where patients suffered cardia arrest during dialysis treatments in 2010. While the company issued a memo to doctors in their own clinics in late 2011, they failed to provide the same information or warnings to other clinics that used Granuflo and NaturaLyte.
After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers. In a situation similar to this one, the FDA later classified the action as a recall.
There are currently more than 460 product liability lawsuits filed in U.S. District Courts throughout the United States against Fresenius Medical Care, all involving nearly identical allegations that the company failed to adequately warn about the cardiac risks of their Granuflo and NaturaLyte dialysis products.