FDA inspected LivaNova (formerly Sorin Group) facilities in Munich, Germany in August and September 2015. The company was cited for failing to validate several changes to the sterilization instructions for the Heater Cooler 3T devices.
The changes were apparently never tested “under actual or simulated use conditions.” The FDA found many problems with the instructions, including missing technical parameters (such as the proper amount of bleach to use) and documentation for several aspects of the process.
The FDA said it is “taking steps to refuse entry” of devices made at the company’s facility in Germany. The agency warned:
“These are significant labeling changes that can affect the safety or effectiveness of the device, and therefore require a new 510(k).”
In October 2015, the FDA issued a Safety Communication about the risk of infections about heater-cooler devices.
The problem is that bacteria-contaminated water can aerosolize through the device’s exhaust vents. Since January 2010, the FDA has received 32 reports of patient infections or bacterial contamination of heater-cooler devices.
The devices are associated with Nontuberculous Mycobacteria (NTM) infections, especially in patients undergoing heart surgery. The bacteria is commonly found in water and soil and typically only infects people with weak immune systems.
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