FDA EIR - LivaNova USA Inc. - July 25, 2008

An FDA inspection of Sorin Group USA, Inc. in Arvada, CO, conducted from July 22-25, 2008, resulted in a significant observation documented on an FDA 483. The primary deficiency identified was the company's inadequate complaint handling procedures, specifically its failure to consistently evaluate all complaints to determine if they warranted a Medical Device Report (MDR). The investigation revealed that Sorin Group USA, Inc. did not follow its own Standard Operating Procedure (SOP02 MDR) for assessing potential serious injuries or deaths, as required by regulatory frameworks such as 21 CFR 820.198(a)(3) pertaining to complaint files.

Eleven complaints, dating from January 2008, were cited as examples where incidents involving criteria like "Blood Loss" were not properly evaluated or reported to the FDA. Specific instances included an arterial line disconnection causing significant blood loss and blood leakage during procedures. In response, company management, including Director of Operations Fulvio Acquafresca, acknowledged the deficiency. Sorin Group USA, Inc. committed to revising its MDR procedure, enhancing patient information documentation within complaints, and reviewing the identified complaints for appropriate MDR filing. The company promised to implement corrective actions within four weeks and provide a written response within two weeks.