A heart device manufacturer says it has upgraded the machine to cut down on the risk that it may be spreading bacteria.
Germany’s LivaNova makes the Stockert 3T Heater-Cooler System. The company says that the machine — typically used to regulate body temperature during heart surgery — might have been spreading aerosolized bacteria through its water tanks.
LivaNova tells the FDA that it has developed a vacuum canister and changed the design of 3T’s internal sealing system. The company hopes the changes will cut down on the risk of secondary infections but acknowledges that they won’t eliminate the risk altogether.
The company is also dispatching representatives to contact 3T customers and schedule the upgrades. Any devices in the LivaNova’s deep cleaning centers will be upgraded on-site, the FDA said.