The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

In October 2016, the FDA warned that surgery with LivaNova PLC Stockert 3T heating-cooling devices had been linked to serious and potentially deadly infections.

Recent reports, however, have indicated that it’s not only this particular device that may be to blame. At least four other brands may also expose patients to dangerous bacteria during open-chest surgeries.

Heating-Cooling Devices May Expose Patients to Potentially Deadly Bacteria

The Washington Post reported in October 2016 that at least 28 cases of a serious infection caused by a nontuberculous mycobacterium (NTM) called M. chimaera had been identified in U.S. hospitals, with more reported in Europe.

The FDA notified doctors and hospitals to immediately remove any of the LivaNova devices that tested positive for this bacteria, and to consider limiting the use of all such devices until the manufacturer could find a way to fix the problem.

Heating-cooling devices are used during open-chest surgeries to help monitor the patient’s body temperature. They have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets.

The water in the heater cooling devices never comes into contact with the patient, but the devices have fans and exhaust vents. If bacteria is present on the devices, it can become aerosolized during the operations, and can be blown out into the air of the surgery room where can settle onto a patient’s exposed organs.

The warnings were limited to LivaNova machines because of evidence showing that the machines were contaminated at a single source—a manufacturing plant in Germany.

Though both FDA and CDC (Centers for Disease Control and Prevention) warnings have been limited to the LivaNova device, other brands of heating-cooling devices may also put patients at risk.

Infections Connected with Other Brands of Heating-Cooling Devices

So far, recent warnings about heating-cooling devices have focused on the Stockert 3T and on one type of bacterium: M. chimaera.

This isn’t the only machine that presents a potential risk, however. Back in October 2015, the FDA issued a safety communication concerning all heating cooling devices, noting that any of these devices that include water tanks could transmit bacteria through the air through the device’s exhaust vent.

There have been reports of infections linked with other brands of heating-cooling devices submitted to the FDA’s adverse event database. The Terumo HX2 unit, for example, was the subject of an adverse event report back in September 2013. The patient suffered a similar mycobacterium infection five months after a single lung transplant and cardiopulmonary bypass surgery in which the Terumo was used.

Though the Stockert 3T device is the most popular on the market, there are several other brands, including the Terumo, the Maquet HCU20 and related models (HCU30 and HCU40), and the Cincinnati Sub-Zero 33W and Hemotherm.

In the FDA executive summary prepared for the June 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee, the administration addressed NTM infections associated with heater-cooler devices. The summary identifies reports of patient infections received for each brand of heating-cooling device, and the bacteria associated with each report. The Terumo was the subject of 10 total reports—two involving the bacterium M. avium intracellulare, and eight involving the bacterium M. abscessus.

The Cincinnati had three reports, and the Maquet brands had nine total reports, four (M. chimaera) of which involved the same type of bacteria as that associated with the LivaNova devices.

Clearly, the Stockert 3Ts is not the only heater- cooler device that is associated with these types of infections. Patients who underwent surgery with any sort of heating-cooling device should be aware of potential symptoms associated with these slow-growing bacterial infections.














Comments are closed.

Of Interest