March 3, 2017 — LivaNova (Sorin) has recalled the FlexTherm Heater Cooler, a machine that is nearly identical to the 3T Heater Cooler suspected of causing infection outbreaks.
In a Field Safety Notice (PDF) issued on February 6, LivaNova said it was discontinuing FlexTherm Heater Coolers after thoroughly reviewing its design and concluding that it “does not fully meet user requirements.”
LivaNova manufactures three types of heater-coolers:
- FlexTherm Heater Cooler System
- SIII Heart Lung Machine Modular System: Heater Cooler
- Stockert 3T Heater Cooler System
The FDA approved FlexTherm in January 2014. The 510(k) application cited the 3T Heater Cooler as an “equivalent” device. The biggest differences were a new user interface, materials, and size.
The design changes did not address a design flaw that was recently linked to the 3T — namely, a vent in the back that allows water and bacteria to blow into the air of an operating room. Bacteria that lands in a patient during open-heart surgery can cause deadly infections.
Earlier this year, a study found outbreak strains of the bacteria Mycobacterium chimaeria in 80% of heater-coolers that were tested, suggesting contamination might be a “general problem” with the machine. That means nearly everyone who had open-heart surgery in the last 8-10 years was probably exposed.
Last year, the FDA said evidence “strongly suggests” a single source of contamination. Studies have traced M. chimaera to a facility in Germany where LivaNova manufactures the heater-coolers.
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