If you or a loved one recently had heart surgery or cardiothoracic surgery and suffered an infection, the FDA has issued an important warning that might impact you.
According to the FDA, individuals who have had cardiothoracic surgery during which your surgeon used a Stockert 3T Heater-Cooler system manufactured by LivaNova (formerly the Sorin Group Deutschland GMBH). You may have been exposed to bacteria associated with postoperative infections.
The FDA’s warning extends to individuals who were exposed to heat exchangers and/or warning and cooling blankets during cardiopulmonary bypass procedures.
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. Though the systems are closed-circuit, the systems create the “potential for contaminated water to enter other parts of the device and to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”
According to at least one European study, published in April of 2016, the M. Chimaera virus is typically associated with the heating and cooling devices and their use during cardiothoracic surgeries. In a safety communication issued by the FDA, in June of 2016, the agency 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.
Based upon testing of patients in Pennsylvania and Iowa, the M. Chimaera Virus suffered by those patients demonstrated that it is highly likely that the M. Chimaera Virus had a common source, most likely at the manufacturing facility.
If you suffered a post-operative infection following cardiothoracic surgery, you may have rights against the manufacturer.
You should immediately seek legal counsel. If you have further questions or concerns regarding this issue or any other legal issue involving health care, products, or personal injury, please contact our offices.