Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices) 의 리콜

Recall

RC-2016-RN-00886-1

Class II

2016-07-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00886-1

Livanova (sorin) have found that certain oxygenator mounting brackets that include tubing that connects the heater-cooler 3t water circuit to the oxygenator could be a source of re-contamination (with non-tuberculous mycobacteria) of a clean heater-cooler 3t’s water circuit. this tubing is not subjected to disinfection as per the ifu for the heater-cooler. if the heater-cooler 3t user failed to clean and disinfect the heater-cooler 3t resulting in contamination of the heater-cooler 3t and at some point later used oxygenator mounting bracket, the water from the contaminated heater-cooler 3t could cross-contaminate the oxygenator mounting bracket’s internal tubing in which biofilm could develop. if a non-contaminated heater-cooler 3t was later connected to an oxygenator mounting bracket that had been previously cross contaminated, the oxygenator mounting bracket could contaminate the clean heater-cooler 3t.

LivaNova will replace the affected bracket and is providing advice to users on how to dispose of the affected Oxygenator bracket. The existing brackets can be used until a replacement unit can be provided.