| TGA Action ID |
RC-2026-RN-00020-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
EVO IQ Large Volumetric Pumps (LVP)
EVO IQ LVP ANZ
Product Code: ELVP002ANZ
Serial Numbers: SK50400101 - SK50400171
GTIN: 05413765939303
Door Metal Locker spare part
Product Code: 04400121200
Batch Numbers: 30368796, 30370485 |
| ARTG Number |
330210 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Baxter’s complaint review indicates that the defective door hooks have broken early in the pump’s lifecycle. The two metal door hooks are used to lock the pump door in the closed position.
If the metal door hooks break prior to an infusion, the pump will be unable to start an infusion and will display a loading error or the “Loading Guide” screen. If the metal door hooks break during an infusion, the pump will issue a high priority alarm (“Air in Line” or “Door Opened”) and interrupt the infusion. In both situations, the pump must be replaced with a working pump to continue or start therapy.
To date, there have been no reports of patient injury associated with this problem. |
| Instructions for Customers/Users |
- Impacted EVO IQ LVPs can remain in use as long as the Operator’s Manual is followed and any error messages or alarms are addressed promptly.
- Baxter advises customers to have a plan in place for promptly replacing the pump should this problem arise.
- Baxter will be contacting each customer to schedule a screening to simulate clinical use that may help identify defective door hooks. If a defective door hook is confirmed Baxter will coordinate the return of the device to be repaired. |
| Action Commencement Date |
12/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 445 576 - Baxter Customer Service |