| TGA Action ID |
RC-2025-RN-00547-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BD Alaris neXus GP
Catalogue number: GPneXus1
Multiple serial numbers |
| ARTG Number |
130389 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
As previously identified in RC-2024-RN-00873-1, the Alaris Infusion pumps may experience problems associated with a faulty keypad.
For the keypad problems identified there will be no change made to the programmed infusion, despite what the display may be showing. Any infusion program changes require confirmation by the Healthcare professional, which will not be possible while the key remains stuck/pressed. The only operational keys in this scenario would be the ON/OFF button and the HOLD button.
Only the specific Alaris neXus Infusion pumps listed in the customer letter are affected. BD is to replace the keypads in the affected pumps. |
| Instructions for Customers/Users |
Customers are to:
-Locate the affected Alaris neXus GP Infusion pumps listed and prepare to make them available for keypad replacement by BD technicians
-In the meantime, continue to use the Alaris Infusion devices with their existing labelling and Directions for Use.
-Confirm the rate displayed on the screen matches the prescription before acknowledging and starting any infusion, per good clinical practice.
-Continue to service the Alaris Infusion devices per the existing Technical Service manual and servicing instructions.
If customers experience any problems with the BD Alaris Infusion devices, please report as a complaint as per normal process. |
| Action Commencement Date |
16/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 656 100 - Becton Dickinson Pty Limited |