In a Sorin heater cooler lawsuit, the widow of a deceased heart surgery patient claims the medical device caused her husband’s wrongful death.

Plaintiff Melba F. alleges in her lawsuit that the use of a defective Sorin medical device, a Sorin 3T Heater Cooler System caused the wrongful death of her husband, Wayne F., after the device was used in his open heart surgery on July 14, 2015. She seeks damages for herself and for her husband’s estate.

The Sorin (or Stockert) 3T Heater Cooler is a medical device used during heart surgeries to keep organs and blood at a proper temperature during bypass surgeries. Reportedly, these devices are used in more than 250,000 open-heart surgeries annually.

The heater cooler lawsuit claims that the device’s design is defective and allows surgery patients to be contaminated with bacteria. The device includes tanks of temperature-controlled water. Though the water does not come in contact with patients directly, the FDA reports that “there is potential for contaminated water to enter other parts of the device and aerosolize.” According to the FDA, the Stockert 3T Heater Cooler’s design allows for the possibility of bacteria to “exit through the device’s exhaust vent into the environment and to the patient.”

According to the heather cooler lawsuit, the plaintiff’s husband contracted such an infection as a result of the use of the device during his surgery and died as a result of that infection.

Melba’s Sorin heater cooler lawsuit claims that Sorin’s development and testing of proper disinfection procedures for the device was insufficient. She claims that the procedures were conducted “without consideration for the presence of mycobacteria, and the instructions for cleaning/disinfecting the Sorin 3T in the IFU and elsewhere were insufficient to property disinfect the Sorin 3T from the presence of mycobacteria.”

The FDA’s inspection of the device showed four major flaws, according to the lawsuit:

1. The design output includes a cleaning procedure for the U.S. but requires cleaning agents not sold in the U.S.
2. The design verification was not performed in relation to the U.S. cleaning IFU.
3. Risk analysis does not include possible contamination from water held in the tank in relation to the patient, operating room, or operation.
4. Design changes were not adequately verified.

Though the FDA’s assessment of the device only addressed its performance in the U.S., European authorities also reported problems with the device. The European Centre for Disease Prevention and Control reported multiple cases of infection by Myccobacterium chimaera in patients whose open heart surgeries had involved the use of the Socket 3T, starting in 2011.

Melba’s heater cooler lawsuit alleges that “based on these outbreaks in Europe, the FDA’s inspection, and their own investigation and testing, Sorin knew or should have known in 2011 of the association ween non-tuberculous mycobacterium infections and the use of the Sorin 3T when used in open-heart surgeries.”

However, Sorin did not issue a warning to hospitals about possible bacterial contamination until July 2014. Information about possible contamination did not reach the general public until 2016, after Melba’s husband’s surgery.

Melba claims that as a result, Sorin’s continued manufacture and sale of the device recklessly endangered patients.

The Sorin 3T Heater Cooler Lawsuit is Case No. 4:18-cv-03027-JMG-CRZ, in the U.S. District Court for the District of Nebraska.