LifeSite Hemodialysis Access System

Modified on 2009/10/14 21:46 by admin
On November 29, 2001, the U.S. Food and Drug Administration (FDA) issued a warning letter to the President and CEO of Vasca, Inc. of Tewksbury, Massachusetts. The firm manufactures an implanted hemodialysis access system (marketed under the trade name LifeSite) that was cleared for distribution in the United States in August 2000. FDA's New England District Office conducted an inspection of the firm in July 2001.

Based on the findings from that inspection, FDA issued a Warning Letter citing Quality System Regulation (QSR) deficiencies caused the device to be adulterated. The deviations related to complaint handling and a failure to provide a notice of a correction or removal under 21 C.F.R. Part 806. The firm was cited for failing to file Medical Device Reports (MDRs) within 30 days (in 14 instances) and for failure to file MDRs (in 6 specific instances).

The Warning Letter also stated that the device was misbranded and requested significant changes in the labeling. The Warning Letter stated that the firm should revise the labeling to incorporate important new post-market safety data. The labeling should also be revised to warn the user about the risks of such use and expected outcome in patients with a history of multiple access failures or access infections that are catheter dependent for dialysis access, and are not candidates for permanent access placement.

Since LifeSite went on the market in 1998, the device has been the subject of dozens of complaints involving death or injuries.

See your doctor if you have experienced serious health problems after a dialysis procedure. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

See Also

  1. Dialysis: Overview
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