FDA 483 - LivaNova USA Inc. - July 14, 2009

An FDA directed inspection of Sorin Group USA, Inc. in Arvada, CO, was conducted from July 2-14, 2009. The inspection, which included an abbreviated QSIT review of Corrective and Preventive Actions (CAPA) and Production/Process Controls, was also prompted by a CDC inquiry into two sepsis cases potentially linked to Sorin devices at a hospital. The specific devices in question, Stockert III Encore bypass machines and Stockert Heater-Cooler System 3T, are manufactured by Sorin Group Deutschland GmbH, though Sorin Group USA manages all associated complaints and Medical Device Reporting (MDR) for these devices in the U.S. The inspection was conducted under CDRH Assignment #090731 and CP 7382.845, adhering to the regulatory framework for medical device manufacturers. The inspection concluded with no objectionable conditions, and no Form FDA-483 was issued. Review of global complaints found no allegations of bacterial infections, contamination, or sepsis linked to Sorin's products. A previous FDA inspection in 2008 had cited Sorin Group USA for failing to follow its complaint handling procedure regarding MDRs. This issue was confirmed as corrected during the current inspection, with updated procedures clarifying MDR reporting for blood loss. The only finding during this inspection was a verbal observation regarding the need for clearer documentation of the rationale for not reporting certain malfunctions as MDRs, specifically for leaks. Management indicated they would look into improving this documentation to explicitly state why a malfunction would not likely lead to serious injury or death. The company also has active CAPA initiatives addressing leak issues in other products.