Hydrogen Peroxide Monitoring and Design Upgrade Customer Letter

LivaNova

The purpose of this letter is to advise you that LivaNova Deutschland GmbH (“LivaNova” or “the Company”) is executing a voluntary medical device correction for the 3T Heater-Cooler Systems (“3T”). This letter describes immediate action to be taken by you.

Purpose of this Letter

October 18, 2018
The purpose of this letter is to advise you that LivaNova Deutschland GmbH (“LivaNova” or “the Company”) is executing a voluntary medical device correction for the 3T Heater-Cooler Systems (“3T”). This letter describes immediate action to be taken by you.

Reason for this Medical Device Correction
This medical device correction is to:
1) Provide you updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm. This regimen enhances the regimen outlined in Section 6.4 of the Operating Instructions; and
2) Inform you of a design upgrade (vacuum canister and internal sealing) that reduces the risk of potential emission of aerosols from the 3T.

Risk to Health
The 3T Operating Instructions establish disinfection procedures that are designed in part to maintain water quality at a total heterotrophic plate count (HPC) <100 CFU/ml within the 3T heater-cooler water circuit. If the hydrogen peroxide concentration within the water circuit drops below 100 ppm, microorganisms may start to grow in the period between bi-weekly disinfection cycles, possibly to a concentration that exceeds this specification. Although an increased HPC count suggests the growth of microorganisms, it does not necessarily follow that devices are contaminated with non-tuberculosis mycobacteria (“NTM”), whose growth rate extends beyond the 14 days between disinfections.
Although the water in the 3T heater-cooler unit does not come into direct contact with the patient, users should be mindful that aerosols are emitted when the 3T is used, primarily during the patient warming phase and at the end of a procedure, when water is returned to the tanks. Depending on the characteristics of the bacteria and the concentration of bacteria in the water in the tanks, these aerosols may carry bacteria into the operating room environment. Another risk of contamination for the patient is a direct contact transfer of water/solution droplets containing water-borne, pathogenic microorganisms into the surgical field. Some of these microorganisms, such as M. chimaera, could lead to cardiovascular infection, including endocarditis or other deep-surgical-site infections if they come in contact with the patient. These risks were most recently described in the Field Safety Notice issued on October 13, 20161.