The FDA warned patients and doctors today about the risk of a type of bacterial infection posed by the Stӧckert 3T heater-cooler made by Sorin, known as LivaNova (NSDQ:LIVN) since its merger with Cyberonics last year.
Late last year the FDA said it logged 32 reports of patients with infections associated with the devices, with 25 received in 2015. Heater-cooler devices use water tanks to provide temperature-controlled water to keep patients warm or cool during surgical procedures. Although water in the devices does not contact patients, the federal watchdog warned of the potential that contaminated water could enter other parts of the device, which could be aerosolized through its exhaust vent.
In a warning letter to Sorin issued last December, the FDA flagged the Italian cardiovascular device maker over the Stӧckert 3T device, noting a pair of design changes related to reducing biofilm and bacterial growth.
Today the FDA said a European study linked cases of infection by mycobacterium chimaera to samples from Stӧckert 3T heater-coolers used during cardiothoracic surgeries, that were made at a Sorin plant in Germany.
“The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and 1 specific heater-cooler model – the 3T,” the agency said. “FDA believes these [nontuberculous mycobacterium] infections associated with the 3T are rare. However, they are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.”
Testing conducted by Sorin in August 2014 found that the bug had contaminated the German facility’s production line and water supply; new cleaning and disinfection procedures were instituted in September 2014, and further testing in June 2015 showed no sign of M. chimaera infection, the agency said.
“The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T. Currently, efforts are underway in the U.S. to determine if the infections in U.S. patients and M. chimaera isolates from samples taken from the 3T are linked with M. chimaera isolates from European patients who were infected and the M. chimaera previously identified at the 3T manufacturer’s production and servicing facility in Germany,” the FDA said, advising caregivers to monitor patients for signs of the infection.
In April, the FDA said it would hold a public advisory committee meeting of its Circulatory System Devices Panel this week to discuss bacterial infections associated with the use of heater-cooler devices during cardiac surgical procedures.
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