|
|
|
|
|
|
|
Free Newsletters
Archive
My Subscriptions
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers
Regional News
US & Canada
Biotech Bay
Biotech Beach
Genetown
Pharm Country
BioCapital
BioMidwest
Bio NC
BioForest
Southern Pharm
BioCanada East
US Device
Europe
Asia
Market Summary
News
IPOs
Company Profiles
Companies
Events
Research Store
Biotech Events
Post an Event
Real Estate
Business Opportunities
|
|
|
|
|
News | News By Subject | News by Disease |
News By Date | Search News
|
|
|
Fresenius AG Warned on Faulty Kidney Devices
10/7/2010 8:20:43 AM
Boston Business 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, Mass.-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.
|
|
|
|
|
|
|
|
|
|
|