Stockert 3T Heater Cooler System and the FDA

Santa Clara, CASince M. chimaera contamination was found during tests at Sorin’s manufacturing facility in 2014, and its 3T Heater-Cooler devices subsequently recalled, the FDA has kept close tabs on Sorin, now known as LivaNova.

(Sorin Group, the original manufacturer of the heater-cooler devices, merged with Cyberonics, Inc. and the new company was named LivaNova. The Sorin 3T devices were originally branded as the Stockert 3T Heater-Cooler System.)

2010:
Twelve deaths and 79 serious infection events were reported to the FDA between 2010 and 2016. An investigation by health authorities in the European Union found that contamination may have originated in the factories that manufactured the Stockert 3T devices.

August, 2014:   
M. chimaera contamination was found during tests at Sorin, the Stockert 3T manufacturing facility. The manufacturer changed its cleaning and disinfection procedures. But the FDA reported that 3T systems continued to test positive for M. chimaera.

According to Kaiser Health News, the FDA also knew about this potentially deadly infection tied to the 3T heater-cooler devices -- doctors at a York, PA hospital diagnosed an open-heart surgery patient with a serious mycobacterial infection acquired during his surgery. Vincent Karst suffered partial hearing and vision loss, according to his negligence lawsuit, reported by the York Dispatch (Jun 2016).

The FDA issued a final guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Appendix E of the guidance was updated on June 9, 2017 to include heater-cooler devices. The guidance document reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices and the FDA’s current thinking on submissions associated with reprocessed medical devices.

August 2015:
The FDA inspected LivaNova’s Munich manufacturing plant and the agency sent inspectors to the company’s Arvada. The agency ater issued a notice saying inspectors found conditions in the Munich plant that did not conform to FDA standards.

October 2015:
The FDA issued its first safety communication stating that contaminated Sorin Stöckert 3T heater-cooler devices could put patients at increased risk of getting a life-threatening mycobacterial infection. It received 32 adverse event reports on heating, warming, cooling devices (not specifically the 3T) and said they were seeing people with NTM infections. The agency emphasized that the majority of patients acquiring the infection had undergone cardiothoracic surgical procedures.

June 2016:
FDA executive summary comprises 42 pages, including detailed FDA timeline of infections and actions, from Summer 2014 through Spring 2016. The agency received reports of Mycobacterium chimaera infections linked to use of the devices in cardiothoracic surgeries. It warned that patients who received a heart valve, graft, left ventricular assist device or other prosthetic product during surgery face the highest risk of bacterial infections.

October 2016:
The CDC and the FDA issued a 3T Heater-Cooler warning that provides health officials with additional recommendations on how to prevent the spread of infection. While the FDA says that developing the M. chimaera infection is rare, it warns that the infection may take months or even years to develop.

The FDA also found the first incident was reported in 2012. Based on those dates and other information, the FDA estimated that over a half million patients may have been exposed to NTM. At the time, the Sorin 3T heater-cooler was used in roughly half of all heart surgeries performed in the U.S.

June 2017:
In March 2015, the FDA issued a final guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Appendix E of the guidance was updated on June 9, 2017 to include heater-cooler devices. The guidance document reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices and the FDA’s current thinking on submissions associated with reprocessed medical devices.

February 2020:
The FDA issued a new Safety Communication that includes several guidelines aimed at reducing the infection risk during heart surgery associated with the Sorin 3T Heater-Cooler System.