Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Baxter Healthcare EVO IQ Large Volumetric Pumps [Product codes: ELVP001ANZ] [HKMD No.: 200110].
According to the TGA, the manufacturer identified that under-infusions could occur when the pump is operated using a refrigerated solution (2°C - 8°C), which is outside of the pump’s lower operating temperature range of 15°C. The level of under-infusion increases at higher flow rates.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00697-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Aug 2023