These units are widely used in open chest heart surgery as an essential part of extracorporeal circulation but have been suggested as being a risk for infection 7. Fda communication on heater cooler devices for a complete listing of actions the fda has taken on this issue see fda s ongoing evaluation and continued monitoring of reports of nontuberculous. Patients who became ill as well as those who lost loved ones in connection with this device may be able to file lawsuits.
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