| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00898-1 |
| Product Name/Description |
EVO IQ Syringe Pump (EVO IQ SYR ANZ)
Product code: ESYR001ANZ
All serial numbers
GTIN: 05413765581595
ARTG 335743
(Baxter Healthcare Pty Ltd - Infusion pump syringe) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/10/2023 |
| Responsible Entity |
|
| Reason/Issue |
Baxter has identified that after multiple downstream occlusion alarms, the pump may display a “VTBI (Volume to be infused) Complete” alarm even though uninfused fluid remains in the syringe. The mismatch between the volume of fluid actually delivered and the programmed VTBI is dependent on the number of occlusion alarms encountered during an infusion. A greater number of occlusion alarms would result in a larger uninfused volume of fluid.
If one or more downstream occlusion alarms occur, this could lead to insufficient therapy and/or interruption of therapy. Serious adverse health consequences may occur if the patient does not receive the intended dose of the prescribed medication. The resulting harm would depend on multiple patient-related factors, infusion settings, the number of occlusions that occurred, the brand and size of the syringe used, and the therapy being delivered.
To date no reports of serious injury associated with this issue have been received. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Baxter is investigating a correction to the issue and customers will be contacted to provide the correction once available.
In the interim customers are to:
- Ensure the downstream occlusion pressure setting is appropriate for the clinical scenario, prior to beginning an infusion.
- In alignment with standard clinical practice, always check for clamped lines and other sources of downstream occlusion prior to and during therapy.
- For pressure setting selection guidelines, see section 4.4, "Time to Recognize an Occlusion" and 5.3.1, "Occlusion Pressure" in the Operator’s Manual.
- Guidelines for downstream occlusion resolution are in section 4.4, "When Addressing or Clearing an Occlusion" and 8.3, "Occlusion Alarm".
Per standard clinical practice, users should monitor the VTBI, and the volume delivered during therapy. If the total dose is not delivered upon the VTBI Complete alarm, users should reprogram the pump and deliver the remaining volume as necessary. |
| Contact Information |
1800 229 891 - Baxter Healthcare Customer Service |