The device is manufactured in Munich, Germany by LivaNova (formerly Sorin Group). In August and September, FDA inspectors visited the facility and documented extensive problems with instructions for cleaning the Heater Cooler 3T.
For example, changes to the instructions were never tested “under actual or simulated use conditions” and key technical parameters were missing — such as how much bleach to use to disinfect the device. The FDA is now “taking steps to refuse entry” of the devices, warning:
“These are significant labeling changes that can affect the safety or effectiveness of the device, and therefore require a new 510(k).”
The FDA issued a Safety Communication about the risk of infection from heater-cooler devices in October 2015. More than 30 reports of infections and bacterial contamination had been linked to heater-cooler devices since 2010.
Water in the devices does not directly contact a patient, but bacteria in the water can aerosolize through the device’s exhaust vents. Several patients developed serious infections with Nontuberculous Mycobacteria (NTM), a bacteria commonly found in soil and water.