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Surgical Heater-Cooler Resulted in Child’s Heart Infection, Lawsuit Alleges

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A Louisiana couple indicates that a contaminated heart surgery heater-cooler is responsible for causing their young daughter to develop a dangerous and potentially life-threatening infection. 

In a complaint (PDF) filed by Ryan Paul Mitchell, Sr. and DeLacy Lucas in the U.S. District Court for the Eastern District of Louisiana on July 25, their daughter was diagnosed with a mycobacterium abscessus infection following a surgical procedure in August 2017. The family alleges that the injury was caused by a medical device known as a 3T Heater Cooler, which was contaminated with nontuberculous mycobacterium (NTM) bacteria, according to the lawsuit.

The minor child, identified by the initials “R.M.” in the complaint, was exposed to the surgical heater-cooler during an an extracardiac non fenestrated Fontan circulation completion procedure, which is designed to increase the efficiency of circulation in a single ventricle heart malformation.

After the surgery, R.M. developed yellowish drainage at her surgical incision site and was hospitalized less than a month later for a postoperative sternal wound infection and diagnosed with a mycobacterium abscessus infection, which resulted in her being hospitalized until October 2017.

“Over the course of her hospital stay at Children’s Hospital, R.M. underwent numerous procedures under general anesthesia, including an incision and drainage of her sternal wound, several replacements of wound VAC dressings and the placement of a Broviac catheter,” the lawsuit states.

The 3T Heater-Cooler was used to regulate R.M.’s blood pressure during the heart surgery, and the lawsuit alleges that the device sold to the Louisiana Children’s Medical Center was contaminated with bacteria that has resulted in a number of similar infections at hospitals nationwide.

The complaint raises allegations similar to those presented in dozens of other surgical heater-cooler lawsuits filed by individuals nationwide, which allege that contaminated devices release bacteria in a mist into the air of the operating room, which may enter the open surgical wound.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Given similar questions of fact and law presented in lawsuits filed nationwide, the dozens of cases filed throughout the federal court system have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

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