| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01368-1 |
| Product Name/Description |
Sorin Group perfusion system – Heater Cooler 3T 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 |
LivaNova is issuing a Recall for Product Correction to inform users about the retrofit of their Heater Cooler 3T devices to implement a vacuum and sealing upgrade. This modification to the internal design of the 3T heater-cooler device will collect any aerosols that are potentially contaminated with Nontuberculous Mycobacterium (NTM), preventing those aerosols from entering into the sterile operating field.
LivaNova is also notifying 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. However, during this period, LivaNova will be able to supply loan units on an as-needed, no-charge basis to ensure continuity of clinical practice. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
LivaNova has completed the development of a TGA approved correction that mitigates against this potential contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. This correction will be implemented by an onsite enhancement of units currently in use by LivaNova service personnel or a local agent. Although this issue is less likely when the 3T device’s water system is maintained according to the current IFU, this product correction will mitigate against the reasonably foreseeable hazard of patient infection which may be potentiated by poor maintenance practices.
This action has been closed out on 19/02/2019 |
| Contact Information |
03 9799 7444 - LivaNova |