A husband and wife from South Carolina are suing the maker of the Sorin 3T cardiac heater-cooler, alleging the device caused the husband to develop a potentially deadly heart surgery infection.

Plaintiff Phillip W. underwent an aortic valve replacement and bypass procedure in May 2014, during which LivaNova’s Sorin 3T Heater-Cooler System was used.

Over the following days and weeks, Phillip’s condition began to deteriorate and he presented with mild symptoms of fever and weakness and eventually developed pneumonia.

In June, Phillip was treated for a red rash around his sternal wound and incision that appeared to be swollen and contain fluid.

He was placed on antibiotics and had to undergo debridement of the wound as well as a pectoralis major muscle flap procedure, which has severely affected the use of his arm.

A little over a month later, Phillip was readmitted to the hospital for delayed healing of his surgical wound, where it was discovered he was suffering from a potentially deadly heart surgery infection.

Phillip says his treatment for the infection is ongoing, and he contends that the cardiac heater-cooler device used during his heart surgery exposed him to the non-tuberculosis mycobacteria that led to his potentially deadly infection.

According to the cardiac heater-cooler lawsuit, the injuries, conditions, and complications Phillip suffered due to the Sorin 3T System include excruciating pain and weakness, along with excessive and debilitating medical treatment.

Phillip claims that LivaNova had knowledge of the catastrophic injuries and complications caused by their cardiac heater-cooler, including the possibility of deadly heart surgery infection, but failed to adequately warn patients and the medical community of the device’s risk of infection.

He is seeking punitive and actual damages for his injuries and damages attributed to his infection. His wife, Karen A., joins the complaint with a loss of consortium claim.

What is a Cardiac Heater-Cooler Device?

Cardiac heater-cooler devices like LivaNova’s Sorin 3T System are used to warm or cool a patient’s blood during heart surgery and other medical procedures.

The device consists of tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.

Although the water in the circuits does not come into direct contact with the patient, the Centers for Disease Control reports that contaminated water can enter other parts of the heater-cooler or transmit through the air via the system’s exhaust vent and onto the patient.

FDA: Cardiac Heater-Cooler Devices Linked to Deadly Heart Surgery Infection

In October 2015, the FDA issued a safety communication regarding problems associated with medical cardiac heater-cooler systems.

According to the warning, at least 32 adverse event reports were linked to the devices between January 2010 and August 2015.

Only 8 of the reports came from inside the U.S, associated with 3 events describing patient infections. The rest mainly came from Western Europe.

If you or a loved one suffered a serious or deadly heart surgery infection following a procedure in which a cardiac heater-cooler device such as LivaNova’s Sorin 3T System may have been involved, a consultation with an experienced dangerous medical device attorney may be in order.

You may be entitled to compensation for your pain and suffering by filing a cardiac heater-cooler infection lawsuit.

The Cardiac Heater-Cooler Infection Lawsuit is Case No. 8:16-cv-02688-MGL, in the U.S. District Court for the District of South Carolina, Anderson Division.