On April 3, 2006, Gambro Renal Products announced that part of its corrective action plan in response to concerns raised by the U.S. Food and Drug Administration (FDA) over issues with its Prisma dialysis device will be a new software version for the device. The company said the software will improve the system’s fluid balance management. Gambro also said it continues to train and inform customers and intensive care personnel on the proper use of the Prisma dialysis machine.

Gambro has come under fire recently for problems with its Prisma device related to its alarm functionality, which may cause excess fluid to be removed from a patient on kidney dialysis, leading to severe personal injury or possible kidney failure. The new software and associated training module will be released for a gradual rollout in the summer of 2006.

Source: “Gambro to develop new software for Prisma system in response to FDA concerns,” Forbes, April 3, 2006.