Myobacterium Chimaera Infections and the Sorin 3T Heater-Cooler System.

Many patients who underwent cardiothoracic surgery where a 3T heater cooler unit was used have been developing serious life-threatening infections. Sadly, in many cases, patients have died. These infections have been identified as Mycobacterium chimaera (M. chimaera). Many have been linked to the 3T heater cooler unit manufactured in Germany by LivaNova (formerly Sorin). The Sorin 3T Heater-Cooler System is used during open-heart surgery to regulate a patient’s body temperature.

Why is LivaNova (formerly Sorin) being sued?

Lawsuits against LivaNova allege that the 3T heater cooler unit was contaminated with Mycobacterium chimaera from the tap water at the manufacturing plant. Once contaminated, the 3T aerosolizes. In other words, it releases the Mycobacterium chimaera into the operating room where it can reach the surgical site, infecting the patient.

In 3T heater cooler units manufactured before August 2014, LivaNova used tap water in the finished device testing. Moreover, LivaNova was not disinfecting nor drying the devices before shipping them from their manufacturing plant in Germany to hospitals in the United States. This provided a breeding ground for microbial growth which formed a biofilm. Crucially, biofilm cannot be eliminated with routine disinfection once formed inside the 3T heater cooler unit.

In 2011, LivaNova engineers identified delivering the 3T heater cooler units to hospitals completely dry as its number one safety priority. Nevertheless, LivaNova failed to implement safe manufacturing processes. LivaNova used unfiltered tap water during production testing. Nor did it disinfect or dry the 3T heater cooler units before shipping them to hospitals in the United States.

Many hospitals throughout Pennsylvania and the United States have notified cardiac surgery patients who underwent surgery where a 3T heater cooler unit was used about the potential exposure to Mycobacterium chimaera and the risks of infection.

What should you do if you have been diagnosed with M. Chimaera?

Jaime Jackson Law represents patients who have developed M. Chimaera infections following cardiac surgery in Pennsylvania and other states. If you or a loved one has been diagnosed with M. chimaera following cardiac surgery, please contact Jaime Jackson Law using the web form found here.

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