| TGA Action ID |
RC-2026-RN-00213-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
EVO IQ Large Volumetric Pumps (LVP)
Product Code: ELVP002ANZ
GTIN Number: 05413765939303 |
| ARTG Number |
335743 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A subset of pumps may not turn on, show a blank screen, or display a system error and become inoperable due to software control leading to mainboard failure. This would occur during pump power on and before infusion initiation, therefore a delay in therapy may occur while the user replaces the pump. There is no risk to active infusions.
Baxter has received complaints associated with this problem, however there have been no reports of serious injury. |
| Instructions for Customers/Users |
Customers can continue to use the impacted EVO IQ LVP devices while following the Operator’s Manual.
Customers are to:
- Keep the pump plugged in where possible and ensure it is properly charged.
- Promptly replace the pump to reduce potential delays in treatment and contact Baxter Technical Support should this problem occur.
Baxter is developing a software update and will contact all customers to upgrade the pumps once the software update is available. |
| Action Commencement Date |
23/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 229 837 - Baxter Healthcare Customer Service |