The FDA’s warning extends to individuals who were exposed to heat exchangers and/or warning and cooling blankets during cardiopulmonary bypass procedures.
In at least one European study, published in April of 2016, the M. Chimaera virus was found to be typically associated with the heating and cooling devices and their use during cardiothoracic surgeries. In June of 2016, the FDA warned that testing conducted by the manufacturer found M. Chimaera contamination on the production line and water supply at the 3T manufacturing facility. These devices were then distributed worldwide.
According to the FDA, heater/cooler devices are commonly used during cardiothoracic procedures to warm or cool a patient in order to optimize care.
The devices, including the 3T device at issue, have water tanks that provide temperature controlled water to external heat exchangers or warming/cooling blankets.
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