The U.S. Food & Drug Administration (FDA) recently released a safety warning for the German-made Stockert 3T Heater Cooler System, which is a medical device commonly used in hospitals throughout the United States during heart surgeries. This October 2016 warning comes after two earlier FDA safety communications, one in June 2016 and one in October 2015, about the heater cooler device’s association with Mycobacterium chimaera (M. chimaera). M. chimaera is a slow developing form of nontuberculous mycobacterium (NTM), which is a bacteria that can cause infections in patients who have had invasive procedures or who have weakened immune systems.
The attorneys of Abbott Law Group are currently investigating claims on behalf of those who were seriously injured or died as a result of developing an infection after undergoing surgery in which a heater cooler device was used. Contact our law firm today for a free heater cooler lawsuit consultation.
What is a Heater Cooler?
The Stockert 3T Heater Cooler System, which is the type of heater cooler at the center of the FDA safety warning, is manufactured in Germany by LivaNova PLC (formerly Sorin Group Deutschland GmbH). The device is used during cardiac surgeries to keep a patient’s organs and circulating blood at the ideal temperature throughout the operation, which has been shown to improve results and recovery time.
The heater cooler works by transporting the heated, or cooled, water from the device’s water reservoir to external heat exchangers or warming blankets. While the equipment and the temperature-controlled water do not come in direct contact with the patient, there is the possibility of the water evaporating or getting sprayed into the air of the operating room.
The problem with this is that bacteria can grow in the device’s water reservoir, so when the water gets into the air of the operating room and subsequently into the patient’s open chest during surgery, the patient runs a serious risk of developing M. chimaera.
If you or a loved one had surgery and subsequently developed M. chimaera or NTM, contact Abbott Law Group today to discuss your legal rights.
Stockert 3T Heater Cooler Infection Symptoms
The heater cooler is used in approximately 250,000 heart-bypass procedures in the U.S. each year, and the Stockert 3T Heater Cooler System is used in about 60% of these procedures. This means that nearly 150,000 Americans run the risk of developing M. chimaera and subsequent infections after having a cardiac surgery. M. chimaera and subsequent infections are difficult to diagnose because the symptoms are often very common of any sickness and they often occur months and even years down the road, given that it is a slow developing form of NTM.
Some of the symptoms of heater cooler infections include:
What makes matters worse is that there is no test to determine whether a person has been exposed to the bacteria. According to the Centers for Disease Control and Prevention (CDC), heater cooler M. chimaera infections can only be diagnosed by growing and analyzing the bacteria by laboratory culture, but the slow-growing nature of the bacteria can require up to two months to rule out the infection.
Heater Cooler Infection Lawyers
If you or a loved one developed M. chimaera or subsequent infection after undergoing cardiac surgery in which a heater-cooler was used, you may be entitled to compensation for past and future medical bills, lost wages, loss of future earnings, pain and suffering, punitive damages, and other damages.
However, it is vital that you contact our lawyers as soon as possible as Florida’s Statute of Limitations restricts the amount of time a plaintiff has to file a lawsuit against the party responsible for his or her damages.
The attorneys of Abbott Law Group have over thirty years of experience handling personal injury and wrongful death cases involving a defective or dangerous medical device like the Stockert 3T Heater Cooler System. Contact our team of attorneys today for a free heater cooler lawsuit case evaluation.