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Did Manufacturer of Medical Device Know About Safety Concerns Long Before Notifying Hospitals?

Heater-cooler medical devices used during cardio-thoracic surgeries in hospitals are recent subjects of investigation by the Centers for Disease Control and Prevention. One such device is the Stockert-Sorin 3T heater coolers, manufactured by Sorin Group USA located in Arvada, Colorado. (The Sorin Group recently merged to form LivaNova)

A MAUDE Adverse Event Report contained on the FDA’s website indicates that on August 1, 2014, a healthcare facility reported to the FDA that 15 patients tested positive for atypical mycobacterium infections. It was stated that the common denominator in the patients’ surgical site infections was the Sorin 3T heater profusion machine. Of the 15 infected patients, four died.

According to the MAUDE Report, the device was pulled from service and cultured at the facility. The results indicated mycobacterium in the water. Again, according to the MAUDE Report, the hospital reported the 15 incidents to the manufacturer, Sorin Group, on June 19, 2014.

It is unclear what actions, if any, were taken by the manufacturer between June, 2014 and June, 2015. However, it appears that it was not until a year after the incidents were reported to it that the Sorin Group sent a “Field Safety Notice” about the Heater-Cooler systems to facilities which were sold the machines.

The Notice dated June 15, 2015 reveals, seemingly for the first time, the suspicion that the device could contaminate surgical sites. It states:

Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to our Instructions for Use. Without vigilant performance of the disinfection and maintenance procedures……organisms can multiply in a heater cooler device and ………..colonize within the device. Once colonized, there is a possibility that bacteria can become aerosolized when the heater cooler device is operated and serve as a source for contamination….

The Notice also provides instructions to users regarding what actions the facility should take to assure the cleanliness of the water used in the machines.

In early August, 2015 the Sorin Group issued an “Update” to the previous “Field Safety Notice”. The “Update” advises that the measures provided for cleaning and disinfecting in its June, 2015 Notice were incorrectly supplied with products sold and used in the United States. Instead, the instructions were meant for the products sold in the European Union.

In sum, it appears that a device used during critical surgeries caused transmission of serious infection. The manufacturer of the device, on notice of the dangers, waited a year to notify facilities of the serious nature of the problem and offer instructions on how to minimize chances of bacterial infection in the future. And even after the instructions were updated by the manufacturer, they were incorrect as provided with US-sold products.