FDA Issues Warning Letter to LivaNova for Validation Failures

March 11, 2016

A lack of documented testing of updated instructions for use for cleaning a heater-cooler system has helped earn LivaNova an FDA warning letter.

In the Dec. 29, 2015, warning letter, the FDA takes LivaNova — formerly Sorin Group — to task for not testing the IFU for the 3T Heater-Cooler System in actual or simulated conditions. “Your firm has received complaints of patient deaths due to infection from non-tuberculosis mycobacteria (NTM), specifically mycobacteria chimaera, since January 2014, where the cause of the infection appeared to be 3T devices colonized with the mycobacteria,” according to the letter, which followed inspections of the company’s Munich, Germany, facility from Aug. 24 to Aug. 27, 2015, and its Arvada, Colo., facility from Aug. 24 to Sept. 1, 2015.

A company investigation revealed that facilities using the devices had not been following the cleaning IFUs, potentially leading to the infections.

The letter also hits the company for inadequate validation of its new process for cleaning, drying and disinfecting and for inadequate medical device reporting procedures.

LivaNova says it is working to remediate the FDA’s inspectional observations.

Create a solid, risk-based device software validation plan that will sail through any FDA inspection. Order Implementing an 11-Step Plan for Device Software Validation and Verification, which will outline exactly what FDA inspectors are being trained to look for in terms of device software verification and validation.