| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00239-1 |
| Product Name/Description |
MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors
-QUADROX-i(D) adult, small adult, paediatric and neonatal with Softline and Bioline Coating
-PLS-i gas exchanger in PLS sets
-PLS gas exchanger in HIT
-PLS sets
-Quadrox-iR with Softline coating |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Outlet connector detachment may result in rapid blood loss which could cause serious injury or death. This issue was originally reported under recall RC-2012-RN-00551-3. Although the correction implemented for the previous recall reduced the incidence rate of detachment from 0.01% to 0.001%, a patient death potentially attributed to detachment of the outlet connector was reported recently. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are requested to continue to confirm the integrity of the oxygenator prior to use. The devices should only be used if the connector is secure. Maquet is implementing a stainless steel retainer clamp as a short term correction. A permanent mechanical fitting is currently under development and is expected to be implemented in late 2013. This action has been closed-out on 14/04/2016. |
| Contact Information |
1300 304 372 - MAQUET Australia |