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

An FDA inspection of Sorin Group USA, Inc., a medical device manufacturer, was conducted from July 2-14, 2009. This directed inspection, guided by FDA regulatory assignments, covered the company's complaint handling, Medical Device Reporting (MDR), Corrective and Preventive Actions (CAPA), and production controls. A key focus was to address an inquiry from the Centers for Disease Control (CDC) regarding two sepsis cases potentially linked to Sorin's Stockert III Encore bypass machines and Heater-Cooler System 3T, though these specific devices are manufactured by Sorin Group Deutschland. Crucially, the inspection did not identify any objectionable conditions, and no formal FDA-483 Inspectional Observations were issued. An earlier observation from a July 2008 inspection, concerning failures in following complaint handling procedures for MDRs, was confirmed corrected. Extensive review of complaints, including those related to the CDC's inquiry, found no evidence linking Sorin's devices to sepsis, bacterial infections, or contamination incidents. The inspection also reviewed issues such as pinholes found in oxygenators (manufactured by Sorin Group Italia) and leaks in heating/cooling blankets (contract manufactured), with ongoing investigations and corrective measures in place by sister companies or suppliers. Although no formal violations required action, the FDA verbally advised management to improve the clarity of documentation for justifying why certain malfunctions were not reported as MDRs, specifically detailing the rationale for deeming them unlikely to cause serious injury or death.