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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.
In a letter sent to the Tewksbury-based company on Nov. 29, the Food and Drug Administration accused the company of reporting some incidents late and not investigating some deaths properly, The Patriot Ledger reported Thursday.
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.
LifeSite reduced some side effects - including infection and blood clots - that are associated with dialysis, the company said. But in its letter, the FDA said it found 129 complaints in the company's files involving deaths or serious injuries.
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 Web site Wednesday, 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. About 3,000 patients in the United States have used LifeSite since the FDA approved it last year. The device was approved in Canada in 1999 and in Europe in 1998.
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