FDA Warning Letter Sent to Fresenius Over Dialysis Product Design

Federal regulators have issued a warning letter to Fresenius Medical Care, the nation’s largest provider of dialysis services and products, indicating that it failed to adequately study artificial kidneys used in its dialysis machines. 

The company announced the FDA warning letter in a press release to investors on March 14, indicating that the FDA criticized the company for not making sure that the dialyzers that were manufactured adequately matched the actual design specifications.

Specifically, Fresenius “did not conduct adequate design verification studies of its electron beam sterilized polysulfone dialyzers,” which were manufactured at its Ogden, Utah, facility.

Although the company received clearance for the dialyzers in December 2000, the company indicates that the design validation for the artificial kidneys is incomplete.

Fresenius has indicated that it will work with the FDA to address the agency’s concerns as soon as possible. The letter did not call for a Fresenius artificial kidney recall.

Fresenius Problems with Dialysis Products

The warning letter comes as Fresenius is under close scrutiny following a NaturaLtye and GranuFlo recall, which the FDA forced the company to issue after the company warned about an increased risk of cardiac arrest and sudden death during dialysis treatments.

Questions have been raised about whether Fresenius withheld information about the risk of problems during dialysis treatment with Granuflo and NaturaLyte. Although the company sent an internal memo to it’s own clinics in late 2011, they failed to inform medical providers at competing clinics that used their dialysis products about the importance of monitoring patients until March 2012. The FDA classified this warning as a recall.

An increasing number of Fresenius dialysis lawsuits have been filed nationwide on behalf of individuals who suffered heart attacks or lost loved ones to heart problems after dialysis treatment with NaturaLyte and GranuFlo.

All of the lawsuits involve similar allegation, claiming that the company failed to provide adequate warnings about the risk of complications during Granuflu  or Naturalyte dialysis treatment, including the importance of monitoring patients’ bicarbonate levels to avoid a risk of sudden cardiac arrest or death.