| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01370-1 |
| Product Name/Description |
Sorin Group perfusion system – Heater Cooler 1T devices
All Serial Numbers
ARTG Number 194514 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
The LivaNova 1T machine requires a vacuum and sealing upgrade to mitigate against the risk of aerosolisation of the internal cooling water into the sterile operating zone during use.
This design modification is unavailable for the 1T heater-cooler device, which is no longer manufactured nor sold. There have been no reported cases of the newly identified risk of NTM infections for patients exposed to the 1T heater-cooler device. However, LivaNova will replace users’ existing 1T heater coolers with 3T heater-cooler units that have undergone a vacuum and sealing upgrade at no cost to ensure that all customers have the latest, state-of-the art device.
LivaNova is also notifying users that the 3T device will be suspended from the Australian Register of Therapeutic Goods (ARTG) beginning 8 November 2017 for a period of up to 6 months. The reason for this suspension is that the Minncare disinfectant is not listed on the ARTG with the same classification as the 3T device. |
| Recall Action |
Recall |
| Recall Action Instructions |
The LivaNova 1T machine is no longer manufactured or supplied by LivaNova, however, LivaNova has completed the development of a TGA approved correction for the later model 3T machine that mitigates against this potential contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. LivaNova will replace all current 1T machines with corrected 3T machines at no cost to customers. The 1T will be permanently removed from the market and therefore obsolete.
This action has been closed out on 20/02/2019 |
| Contact Information |
03 9799 7444 - LivaNova |