Has anyone heard of lifesite for Hemo and Pd

[Hephs-little-lady]

Oh my goodness, grumpygramp, sounds like a terrible experience! Was that hemo or pd?

[Run8]

Lifesite Dialysis
A kidney dialysis device made by Vasca Inc. has been the subject of 129 complaints involving death or injuries since it went on the market in 1998, federal regulators say. The device, LifeSite, is implanted under the skin and connects a dialysis machine to the patient's blood vessels so the machine can remove wastes from the blood and return cleaned blood to the patient.

In a letter sent to the Tewksbury-based company on Nov. 29, 2001, the Food and Drug Administration (FDA) accused the company of reporting some incidents late and not investigating some deaths properly, The Patriot Ledger reported Thursday.

LifeSite reduced some side effects�including infection and blood clots�that are associated with dialysis, the company said. Thomas Glover, president of Vasca, said patients eligible to use the device are extremely ill. But in 20 cases, FDA investigators "found information to reasonably suggest'' the device "may have caused or contributed to a death or injury'' or that the device malfunctioned in a way that could hurt a patient if the problem recurred, the letter said.

The company filed 14 of the 20 reports with the FDA after a 30-day time limit and did not file six reports at all, the FDA said. The letter, which was posted on the FDA's website, warned that the agency will take regulatory action if the company doesn't address the problems.

Glover said the company has responded to the letter and is in discussions with the FDA. He said the paperwork problems came from a misunderstanding of agency regulations. "There were things that we didn't think had to be reported," he said. "So some of our reports were late.''

The FDA also reported in the letter that the LifeSite device is misbranded in that its labeling �does not bear adequate warnings against use in�pathological conditions, or against unsafe dosage or methods or duration of administration or application, in such manner and form as necessary for the protection of the user.�

The device was approved in Canada in 1999 and in Europe in 1998.

[nursewratchet]

This is old, but I just saw it.  Bear with me.  Lifesites are the cause of many infections, and many deaths.  We used them several years ago at a clinic I worked in.  Scary, dangerous, horrible.