| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01547-1 |
| Product Name/Description |
Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface, Oxygenator with Cortiva BioActive Surface, Oxygenator with Cortiva BioActive Surface, Cardiotomy/Venous Reservoir with Balance Biosurface and Any Tubing Pack containing any of the 3 product numbers listed
Product numbers: BB841, BB811, CB811 & CB841
ARTGS: 182790, 182789, 223064 and 221965 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/02/2023 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic recently identified an upward trend of complaints related to the Temperature Monitoring Adapter (TMA) located on the Affinity Fusion Oxygenator. The complaints indicate that the Temperature Monitoring Adapter (TMA) had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
There have been 83 complaints reported globally, with one in Australia, of TMA separation from the oxygenator. The investigation to date indicates reduced connection strength for TMA connections resulting in detachment prior to or after the procedure. In all instances, the TMA separation only occurred pre- or post-procedure, and there were no adverse patient impacts reported.
To date, no TMA events have been reported during a procedure. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Medtronic is in the process to design new devices and are informing that impacted devices will be replaced upon availability of the non-impacted devices. New devices are anticipated to be available by end of 2023.
In the interim, Medtronic are advising to continue to use Affinity Fusion Oxygenator and the TMA for arterial temperature monitoring. Customers are also advised to ensure there is minimal torque applied to the oxygenator TMA when attaching or detaching the temperature probe and minimize manipulation of the TMA probe connection during the clinical procedure.
This action has been closed out on 1/5/2024. |
| Contact Information |
0417065227 - Meredith - Medtronic |