Lifesite Dialysis
The Lifesite Dialysis device is implanted under a patient's skin to connect the dialysis machine to the patient's blood vessels, allowing waste to be removed from the blood and clean blood to return to the patient. Lifesite Dialysis is intended to reduce side effects associated with dialysis, such as infection and blood clots.
An FDA investigation found 129 complaints in the files of Vasca Inc., the producers of Lifesite Dialysis, involving deaths or serious injuries. In 20 cases, FDA investigators ``found information to reasonably suggest'' the Lifesite Dialysis 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.
According to the FDA, the makers of Lifesite Dialysis filed 14 of the 20 reports with the FDA after the 30-day time limit and did not file six reports at all.
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