A married couple from Pennsylvania filed a mycobacterium chimaera lawsuit in U.S. District Court for the Eastern District of Pennsylvania on Feb. 23, 2018.

Plaintiffs Robert J. and Jean J. are bringing their legal complaint against the LivaNova Co., makers of the Sorin 3T heater cooler device. They allege in their mycobacterium chimaera lawsuit that the heater cooler device was responsible for Robert’s infection.

What is a Heater-Cooler Device?

According to the mycobacterium chimaera lawsuit documentation, a heater-cooler device is used during open heart and other invasive chest cavity operations. Its primary purpose is to help maintain a patient maintain a homeostatic internal temperature.

A heater-cooler device, such as the Sorin 3T, has a closed internal water tank from which it draws to pump through a heat exchanger. The surgical patient’s blood is pumped into another chamber close to the exchanger, but not in direct contact, to gently warm it.

Alleged Problems with the Sorin 3T Heater Cooler

In the mycobacterium chimaera lawsuit, the water tanks of a Sorin 3T heater-cooler device allegedly harbor a bacterium that in the open day-to-day environment is rather benign. In the context of a sterile operating room field, however, this bacterium is dangerous.

The water tanks allegedly aerolize vapor containing this bacterium through the device’s exhaust system which can break into the sterile area and infect a very vulnerable patient.

The Plaintiff’s Experience

Robert alleged he had an open chest surgery at Thomas Jefferson University Hospital in Philadelphia, Pa. on Aug. 27, 2015 for a bio-prosthetic mitrovalve replacement in his heart. He was discharged seven days later after what the mycobacterium chimaera lawsuit describes as an uneventful post-op recovery.

Two years later, the plaintiff alleges he started to drop weight inexplicably and experience unusual tiredness. In June 2017 he was rushed to Jefferson’s emergency room with symptoms that resembled those of a stroke.

Upon admission to the facility, he was put through numerous diagnostic tests where a few problems were found including vegetation on the mitral valve and liver function issues.

Robert alleges he was put on a regimen of IV antibiotics but, even after this was treatment was concluded, he continued to have symptoms that required multiple trips to the hospital. It wasn’t until September that his blood was tested to mycobacterium chimaera. This test came back positive on Oct. 11, 2017, according to the couple’s complaint.

The plaintiff says he was informed that he needed to have his valve replaced if they were able to get his health stabilized. But to date, he claims, he has lost over 100 pounds, is severely malnourished and requires feeding tubes. He has end-stage kidney disease from multiple runs of antibiotics necessary to fight the infection.

Thomas Jefferson University Hospital Sends Out an Announcement

In June 2017, Thomas Jefferson University Hospital sent out an announcement identifying the exposure of open chest surgery patients over the past four years to a life-endangering bacterium from their Sorin 3T heater-cooler devices. The announcement suggested that patients contact their physicians.

The hospital identified the bacterium as slow-growing and capable of producing varied symptoms of infection up to six years after contraction. The signs could be anything from fevers to night sweats, flu-like muscle and joint pain, fatigue and weight loss.

The Mycobacterium Chimaera Lawsuit is Case No. 2:18-cv-00831-CDJ in U.S. District Court for the Eastern District of Pennsylvania.