Device product
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.
Z-0063-2019
Product summary
- Event
- Event 80941
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270 units
- Official record key
device-enforcement:Z-0063-2019
Official wording
Reason: 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.
Code information: UDI 10613031860221
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.