The wife and children of a man who died of a serious infection after surgery have filed a lawsuit against LivaNova, alleging his death was caused by use of a defective heater cooler device during the procedure.

The late Daniel B. leaves behind his wife Carol and children, Heather and Jason. According to the family’s heart surgery infection lawsuit, Daniel underwent open heart surgery at Kaiser Foundation Hospital in Los Angeles. During his surgery, a cardiac heater cooler device was used to regulate his body temperature.

Unfortunately, the family says that in the months and years after surgery, Daniel developed a serious infection that was found to be non-tuberculous mycobacterium (NTM), an infection commonly associated with the use of a contaminated heater cooler device.

What Daniel and his family didn’t know until years after his surgery was that the Sorin HCD heater cooler system used during the procedure may have become contaminated through the water supply at Sorin’s manufacturing facilities, exposing him to the risk of NTM infection.

Indeed, according to the heart surgery infection lawsuit, Sorin actually became aware of the water contamination issue—and its associated risk of NTM infection for patients—in August 2014. However, the family says this information was not released to the public until the FDA issued a safety communication in June 2016.

Daniel’s family filed their heart surgery infection lawsuit on multiple counts, including design defect, manufacturing defect, failure to warn, and negligence. Daniel’s wife, Carol, also filed on a count of loss of consortium. The heart surgery infection lawsuit was filed on June 1, 2018 in the U.S. District Court for the Eastern District of California.

What is a Heater Cooler Device?

A heater cooler device is used during an open-chest surgery to help regulate the body temperature of the patient. The device does this by alternately warming and cooling the patient’s blood as deemed necessary.

The system uses temperature-controlled water, which is then sent to warming and cooling blankets on the body. However, if this water becomes contaminated, patients may be placed at serious risk.

Though there is no direct contact between the water in a heater-cooler system and the patient, it is possible that the water may become aerosolized (move through the air) or even travel through other parts of the device that may come in contact with the patient. Contaminated water used during a major surgery could lead to a serious open-chest surgery infection, multiple agencies including the FDA and the Centers for Disease Control have warned.

More and more patients are filing adverse event reports with the FDA over open-chest surgery infection. An NTM infection after heart surgery may indicate that the bacteria grew in the heater cooler water tank.

In many cases, patients may not actually develop symptoms of the infection for months or even years after the initial exposure during surgery. Reports indicate that the average cardiac surgery patient linked with heater cooler contamination failed to show symptoms of infection after heart surgery for years.

Filing a Heart Surgery Infection Lawsuit

If you or someone you love has suffered from an open-chest surgery infection after heart surgery with the use of a heater cooler device like the Sorin system, you may be able to file a lawsuit or join a class action heart surgery infection lawsuit.

While filing a lawsuit cannot take away the physical and emotional effects of such a serious infection, or bring a loved one back to life, it can help to alleviate the financial burden caused by medical expenses and lost wages.

The Heart Surgery Infection Lawsuit is Case No. 1:18-cv-00754-DAD-JLT, in the U.S. District Court for the Eastern District of California.