Gambro Warned for No MDR After Patient Death, Injury

The bloodline division of Gambro Dasco failed to submit timely medical device reports (MDRs) to the FDA after one patient died and another was seriously injured while using its dialysis machines, according to a July 2 warning letter posted on the FDA website last month. Gambro didn’t file MDRs within 30 days of learning that its Phoenix dialysis machines may have caused or contributed to a patient death from mechanical hemolysis and a life-threatening drop in another patient’s blood pressure, the letter says. “We are working closely with the FDA to address the concerns raised in the warning letter,” Anne Bonelli, director of marketing and communications for Gambro, said.
Devices and Diagnostics Letter