A heart surgery patient claims in a lawsuit that he contracted an infection as a result of a contaminated cardiac heater-cooler used during his procedure.

LivaNova’s Sorin 3T Heater-Cooler System was used during plaintiff Thomas F.’s cardiac bypass grafting procedure performed in April 2014.

The Sorin 3T uses water to keep the blood at a normal temperature during open-heart surgeries.

Heart Surgery Patient Contracts Infection

Nearly two months after being discharged from the hospital, Thomas began to experience pain at the incision and see some redness around the incision site.

Blood tests proved that he had contracted an m. abscessus infection. He was given antibiotics, but the doctors did not know at the time exactly how Thomas had contracted the infection.

The m. abscessus (mycobacterium abscessus) is a rare non-tuberculosis mycobacterium infection that can be deadly.

As a result of contracting the infection, the heart surgery patient had to undergo numerous other surgical procedures in addition to a wound vac, a PICC line and a long course of antibiotics.

A wound vac is a vacuum dressing that promotes healing by creating negative pressure. A PICC line is a Peripherally Inserted Central Catheter inserted in the bend of the elbow and is used in extended antibiotic therapy.

Cardiac Heater-Cooler Found to Pose Bacterial Risk

The FDA issued a Class II recall of the Sorin 3T System due to the “potential colonization of organisms, including mycobacteria, in Sorin Heater Cooler devices if proper disinfection and maintenance is not performed per instructions for use.”

In October 2016, the FDA recommended further warnings to health officials regarding the prevention of the spread of the infection.

These recommendations include using new accessories, tubing and connectors with the devices, and directing the exhaust fan away from the heart surgery patient.

The FDA also warns patients to be aware that there is an increased risk of infection if you receive a heart valve, graft, left ventricular assist device (LVAD), or any other prosthetic product, or have had a heart transplant.

The Sorin 3T units have an exhaust vent that could send bacteria into the air.

The airborne bacteria can land in the chest cavity during the operation and plant particles of infection that can develop months or years after exposure.

Cardiac heater-cooler units are used during 250,000 open-heart bypass surgeries every year. Nearly 60 percent of those machines are the German-made models that have been linked to possibly deadly infections since 2006.

In response to the growing evidence of bacterial problems, Sorin issued a Field Safety Notice Letter that outlined new instructions for use of the Sorin 3T System.

According the lawsuit, Sorin said it provided the letter to:

• Remind users of the importance of following the company’s disinfection and maintenance procedures;
• Inform users that it is possible bacteria can become aerosolized when the device is operated, serving as a source for contamination; and
• Provide users with updated instructions for use regarding disinfecting and maintaining the device.

The lawsuit says, “Upon information and belief, the Defendants knew or should have known that design and/or manufacturing defects in its Sorin 3T System made it susceptible to bacterial colonization, specifically Myobacteria, despite any cleaning and disinfection procedures utilized.”

If you or someone you know is a heart surgery patient who developed an infection after surgery during which a cardiac heater-cooler unit was used, you could be eligible for compensation from the device’s manufacturer.

The Cardiac Heater-Cooler Lawsuit is Case No. 6:16-cv-02307, in the U.S. District Court for the District of South Carolina, Greenville Division.