A woman has filed a lawsuit after contracting a heater cooler bacterial infection following open heart surgery.

Plaintiff Patricia F. underwent an aortic valve replacement procedure on Feb. 18, 2015. A Sorin 3T Heater-Cooler System kept her blood and internal organs at an appropriate temperature during the operation.

However, Patricia alleges the device was contaminated with non-tuberculosis mycobacteria, including one known as M. fortuitum, most commonly found in water and soil. M. fortuitum can take between weeks to years before it manifests into a non-tuberculosis mycobacterium infection.

People undergoing open heart surgery and those who have a deficient immune system are most at risk to develop the heater cooler bacterial infection.

Patricia says she subsequently suffered from bacterial infection due to that exposure. Three months after her operation, Patricia started to notice swelling and drainage from the operative wound. She also developed a low-grade fever and excruciating pain if anything touched the incision area.

She went to the hospital on May 26, 2015 and was diagnosed with an M. fortuitum infection. Patricia “was forced to undergo numerous additional surgical procedures, medical management, and an extensive course of antibiotic therapy,” according to her complaint.

FDA Finds Violations Allowed Spreading of Heater Cooler Bacterial Infection

Sorin submitted a 510(k) premarket notification of intent to market the Sorin 3T System. In June 2006, the FDA determined the device was “substantially equivalent to legally marketed predicate devices that do not require approval of a premarket approval application.”

Hospitals started reporting that patients who had undergone open heart procedures were testing positive for the rare non-tuberculosis mycobacterium infections.

The FDA announced a Class II Recall of the Sorin 3T System in July 2015 because of the “potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per instructions for use.”

As the water used in the device became airborne, bacteria could enter the air and settle in the open cavities of the patient, resulting in a heater cooler bacterial infection. Water is used to provide temperature control, but the water is not intended to come into physical contact with the patient.

Patricia’s complaint says, “Contrary to the Defendants’ representations and marketing to the FDA, medical community, and to the patients themselves, Defendants’ Sorin 3T System has high injury and complication rates, fails to perform as intended, requires patients to undergo additional operations, and has caused severe and sometimes irreversible injuries, conditions and damages to a significant number of patients, including the Plaintiff…”

Sorin is accused of providing “incomplete, insufficient, and misleading instructions, training, and information to hospitals and physicians” to increase the sales volume of the device.

According to Patricia, the FDA sent a warning letter to Sorin on Dec. 29, 2015 to warn Sorin that the FDA’s inspection of the heater cooler’s Germany and Colorado facilities revealed they were not meeting the federal regulations for good manufacturing practice requirements.

The Heater Cooler Bacterial Infection Lawsuit is Case No. 4:17-cv-04049-KES in the U.S. District Court for the District of South Dakota, Southern Division.