Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
US Nationwide Distribution
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2019