Vasca Lifesite Dialysis System
New York Product Liability Attorneys
Vasca, Inc., founded in 1996, is focused on becoming the worldwide leader in
Body Access Management by developing innovative access technologies that improve
the quality of patient care.
With an adage such as that, it may be hard to believe the scrutiny the LifeSite
Hemodialysis Access System has received since its introduction to the medical
community in 1998. At the time of its introduction, many kidney dialysis patients
who require the lifesaving treatment as often as three times a week, believed
it would be a heavenly solution to a hellish situation.
Hemodialysis is the removal of one's own blood and passing it through an artificial
kidney where the blood is cleansed and then returned to the body from which
it came.
The LifeSite System, manufactured by Vasca, Inc., is a medical device which
is surgically placed under the skin (usually under the collarbone) by a specially
trained physician, vastly reducing the painful and unpleasant impairments associated
with dialysis.
The Food & Drug Administration's (FDA) Center for Devices and Radiological
Health (CDRH) regulates medical devices as required by Congress in the Food,
Drug, and Cosmetic Act (Act). The Act defines a medical device as "an instrument,
apparatus, machine, implant, or other similar article that is intended for use
in the treatment or prevention of disease." The term is very broad and
includes items that the public may not consider to be medical devices.
A uniquely designed valve is implanted under the skin and a catheter runs
from the valve to a large vein. The patient receives two valves. One designed
to remove the blood and one designed to return the cleansed blood back into
their system. The distinct shape of these valves allow nurses (who also received
special training for this procedure) to locate and insert the dialysis needle
through the skin and directly into the LifeSite System.
Dialysis Unit staff members have filed complaints claiming that the "specialized
training" they received was immensely insufficient to address significant
aspects of this device and the procedures involved.
With this device, you are always connected, and over time and continued treatments
the insertion point resembles the hole of a pierced ear.
The FDA investigations uncovered 129 incident reports involving death and/or serious injury in Vasca records pertaining to the LifeSite System.
129 deaths and/or serious injury!
Other indications suggest Vasca was well aware of and attempted to conceal
information that usage of the device could result in injury, possibly even death.
It was determined that the LifeSite device was "misbranded" failing
to specify sufficient instructions for usage pertaining to the purposes for
which it was intended.
When questioned about the alleged deliberateness of turning in required reports
to the FDA past the given deadline or not at all, a spokesman for Vasca stated
that there had been a misunderstanding of the agency regulations. Vasca felt
there were things that didn't have to be reported, so reports were late.
So much for improving the quality of patient care….
