Controller, Temperature, Cardiopulmonary Bypass（DWC）

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.

There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.

Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.

The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

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.