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# Updated Safety Communication on Heater-Cooler Devices
- URL: https://www.fdaweb.com/updated-safety-communication-on-heater-cooler-devices/
- Published: 2018-10-19T12:00:00.000Z
- Updated: 2026-09-15T00:39:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142626

FDA has [updated a safety communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623725.htm?ref=fdaweb.com) to reduce potential cardiac surgery infection risks associated with the LivaNova 3T Heater-Cooler Systems. The update follows a 10/18 [medical device correction](http://www.livanova.sorin.com/products/cardiac-surgery/perfusion/hlm/3t?ref=fdaweb.com) letter from LivaNova to inform customers of actions to take to reduce potential infections. The device is intended to provide temperature-controlled water to oxygenator heat exchangers, cardioplegia (paralysis of the heart) heat exchangers, and warming/cooling blankets.

The correction letter provided updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm, according to the agency. It also announced the availability of a design upgrade (vacuum canister and internal sealing) that reduces the risk of potential emission of aerosols from the device.

The update notes that there is the potential for contaminated water to enter other parts of the device and aerosolize. “This could send bacteria through the air and through the device's exhaust vent or other unsealed pathways, the environment, and to the patient," the update says. In 2015, FDA issued a [safety communication](http://wayback.archive-it.org/7993/20161022044038/http:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm?ref=fdaweb.com) to provide recommendations to help minimize infections associated with the devices.