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Stockert 3T Heater-Cooler Systems
Stockert Heater-Cooler System 3T was manufactured by 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 less hours. It was approved by FDA via 510K process in 2006. It is also called as Sorin 3T, it is currently owned by LivaNova.
Stockert Heater-Cooler System 3T has got linked with the possibility of causing non tuberculous 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 fatality.
Serious Alleged Injuries post-operatively 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
- Persistent cough or cough with blood
- Restricted growth or weight gain in infants
- Loss of energy
In July 2015, FDA issued a recall of this device. October 15, 2015, FDA issued Safety communications, to provide recommendations to minimize patient exposure. Following this, on December 29, 2015 a warning letter was issued after violations were seen in actual inspections and import was restricted. 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.
Law Suits Allegation:
Since, June 2016 complaints are filed against LivaNova for alleged injuries, though the number seems less till date, but 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.
Evidence to be looked for in potential cases:
- 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 Sorin Stockert 3T heater-cooler review should approximately take 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.