The Sorin 3T Heater-Cooler, a medical device used during surgery to cool and warm patients, is at the center of a controversy after both patients and the US Food and Drug Administration (FDA) claim its use has resulted in injuries and death. The companies behind the Sorin 3T Heater-Coolers include Sorin Group USA, Sorin Group Deutschland GMBH and LivaNova PLC. The devices are often used during heart surgeries. Sorin 3T Heater-Coolers use water, warming blankets and heat exchangers to warm and cool patients’ blood. It is designed to enable surgeons to safely and efficiently regulate a patient’s temperature throughout surgery.
Is the Sorin 3T Heater-Cooler Hurting Patients During Surgery?
The manufacturers of the Sorin 3T Heater-Cooler announced in June of 2014 that 15 patients had acquired non-tuberculosis mycobacteria infections (Mycobacterium abscessus/M. abscessus) following the use of the device during their surgeries. Four of the 15 patients died as a result of their infections. The manufacturers sent out a letter to around 180 patients during that time warning them that they may have been exposed to Mycobacterium abscessus during their surgeries.
The Food and Drug Administration issued a recall for the Sorin 3T Heater-Cooler in July of last year. The recall is for an infection risk that the device allegedly poses to patients. Following the recall, the FDA released a safety communication in October of 2015 regarding several reports it had received indicating that the use of the Sorin 3T system was causing problems during surgery. From January 2010 to August 2015, the FDA says that it has received at least 32 reports of bacterial device contamination and patient infections linked to the Sorin 3T.
In July, a patient filed a lawsuit against Sorin Group Deutschland GMBH, LivaNova PLC and Sorin Group USA. In the suit, the patient claims that he suffered a serious infection as a result of the use of the Sorin 3T Heater-Cooler during his heart surgery. He alleges that the infection led to increasing weakness, a high-grade fever and pneumonia. Upon receiving treatment for the infection, the patient discovered he was suffering from M. abscessus.
The Circulatory Systems Devices advisory panel, which is part of the Food and Drug Administration, weighed in on the Sorin 3T problem in June. The panel recommended that the FDA increase awareness about the risks associated with the Sorin 3T and provided several technical recommendations that it believes would make the Sorin 3T safer. As of this writing, the FDA was still deciding what to do about the Sorin 3T Heater-Cooler.
Medical product manufacturers and hospitals have a responsibility to provide patients with a reasonable level of care and prioritize patient safety. If patients are hurt due to a medical device defect, they and their families may be eligible to pursue product liability claims.