Stockert 3T Heater-Cooler Systems

  • Stockert 3T Heater Side Effects Lawsuit - Medical Record Review | Neural IT

Stockert Heater-Cooler System 3T is manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) to provide temperature controlled water to heat exchanger devices, which help regulate patient's body temperature during cardiothoracic, cardioplegia procedures for six or fewer hours. It was approved by the U.S. Food and Drug Administration (FDA) via a 510K process in 2006. It is also called Sorin 3T.

Stockert Heater-Cooler System 3T has got linked to the possibility of causing nontuberculous mycobacteria (NTM) infections, which is specifically Mycobacterium chimera. This bacteria is believed to be emitted through vapors which come from the heater-cooler system and cause deadly infections in vulnerable patients.

As per CDC, above 250,000 heart bypass procedures are performed in the United States every year and heater-cooler devices are used routinely. Also, the risk seems very high with patients who have had valves or prosthetic products. Research says infections caused by this bacteria are severe and can also cause a fatality.

Serious Alleged Injuries may include:

  • Fever lasting for more than one week
  • Night sweats
  • Joint or muscle pain
  • Difficulty in breathing
  • Redness, heat or pus around the surgical incision
  • Nausea/Vomiting
  • Persistent cough or cough with blood
  • Restricted growth or weight gain in infants

FDA Safety Warnings:

  • In 2010, the FDA began receiving reports of patients developing serious infections.
  • In July 2015, the FDA issued a recall of this device.
  • On October 15, 2015, the FDA issued Safety communications, to provide recommendations to minimize patient exposure.
  • On December 29, 2015, a warning letter was issued after violations were seen in actual inspections and import was restricted.

The FDA is constantly following Stockert Heater-Cooler System 3T issues by creating awareness and updating precautions through webinars and safety communications. Systems manufactured prior to September 2014, were asked to be avoided for major surgeries, and special recommendations were advised.

Lawsuit Allegations:

Since June 2016 complaints are filed against LivaNova for alleged injuries. Though the number seems less till date, it will raise soon knowing the overall usage of these systems. Suits will target LivaNova for Faulty device design, Manufacturing contaminated systems, Failure to perform safety testing, Failure to provide appropriate cleaning and disinfection procedures, Failure to warn or alert patients.

Lawsuits filed, claim that the manufacturer failed to warn hospitals and doctors of a potentially life-threatening infection being caused by the device during cardiothoracic surgeries exposing the patients to bacteria from the contaminated heater-cooler devices, specifically the 3T system manufactured by the defendants, and most developed infections resulting in injuries, serious illness, other treatment-related complications, additional surgeries and even death, in some cases.

Two class actions have been filed ( One in March 2016 in the Middle District of Pennsylvania federal, the case is awaiting class certification; second filed in January 2017 in the District of South Carolina, the case is in its early pleading stages (as of 10/2017), and the court is  awaiting plaintiff’s responses to defendants’ motion to dismiss the case.)

Request for the formation of MDL No. 2772 filed in January 2017 denied centralization status in April 2017 for the federally filed cases stating that it would not be beneficial.

Evidences:

  • Usage of Stockert 3T heater-cooler in Operative/Anesthesia, Medical Records
  • Indications for usage of Stockert 3T heater-cooler 3T system in Operative Records
  • Identification of post-operative complications/injuries
  • Severity and Treatment for complications/injuries

Medical Record Review and claim validation of Stockert 3T Heater-Cooler Systems case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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