A Medical Device Daily

Gambro Dasco (Medolla, Italy), a production unit within Gambro Renal Products (Lakewood, Colorado), reported receiving an FDA warning letter concerning the agency's inspection of its Medolla facility that manufactures monitors and indicating concerns about the safety of the Prisma System and the adequacy and effectiveness of Gambro Dasco's quality systems.

It said that the FDA also issued an import alert calling for the detention of Gambro's monitor products — Prisma, Prismaflex and Phoenix — shipped into the U.S.

The company said in a statement, however, that the devices can be used “when directions are followed.“

Last August, Gambro Dasco issued a worldwide safety alert for the Prisma continuous renal replacement system (all catalog numbers), due to reports of “several serious injuries and deaths“ associated with use of the system (Medical Device Daily, Aug. 17, 2005). It said the adverse events were the result of excessive ultra-filtration — fluid being removed from the patient's body — when a monitor operator failed to pay strict attention to the “incorrect weight change detected“ alarm and did not make the necessary correction.

As a follow-up to this safety alert, Gambro said it initiated an advisory notice and field corrective action, including updated Prisma system operator's manuals with an additional warning, a label for customers to place on machines, and enhanced training specifically addressing the “incorrect weight change detected“ alarm.

Jon Risfelt, president of Gambro Renal Products, said that the company takes the agency's concerns “seriously.“ And repeated earlier boilerplate language that the company's “first priority is patient health and safety, and we will continue to cooperate with the FDA to fully and promptly address all issues and ensure that critically ill patients continue to receive the life-saving treatments they depend on.“

Gambro describes the Prisma system — launched in 1995 in Europe and 1997 in the U.S. — as the first intrated kidney hemodialysis system specially designed to perform the complete range of continuous renal replacement therapy for patients in the intensive care unit.