FDA warns Fresenius on faulty kidney devices

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FDA warns Fresenius on faulty kidney devices

By Julie M. Donnelly
Wall Street Journal

The U.S. Food and Drug Administration has sent a letter to Fresenius Medical Care Holdings Inc. warning the company that its facilities used to produce kidney dialysis devices are out of compliance with FDA standards. The FDA said the findings in the letter followed an inspection of the Waltham-based  company’s plant between June 15 and August 6, 2010.

The letter, dated September 15, claims that Fresenius has not taken sufficient action to address a faulty product, called a Liberty Cassette, which is a disposable part for home dialysis machines. The FDA said that the company investigated 118 complaints between 2001 and 2009 that the devices leaked, causing six adverse patient reactions and two cases of peritonitis.  While the company put a hold on shipping the devices, and ordered a rework of the device in November of 2009, it did not issue a recall, or take other action to reduce patient risk, for devices already on the market.

The FDA also determined that the company did not adequately address a problem with its Naturalyte Acid Concentrate products, another component for home dialysis care. The company reported that a patient in 2007 received the wrong dosage of the product, leading to an adverse reaction. The FDA said it uncovered other similar instances of confusion over dosages, and yet the company did not launch an investigation into product labeling.

The FDA said the company also inadequately investigated two complaints about a possible patient reaction to this product, that resulted in the patient losing consciousness on two occasions, and requiring CPR.

The FDA said that while Fresenius has proposed corrective actions to resolve these problems, including a voluntary recall of some Liberty Cassettes, the plan is inadequate. An acceptable plan would have to detail how the company will prevent such problems from happening in the future, the FDA said.

http://www.masshightech.com/stories/2010/10/04/daily39-FDA-warns-Fresenius-on-faulty-kidney-devices.html