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 posed a medical device safety alert concerning Baxter Healthcare SA EVO IQ Syringe Pump [HKMD No.: 210183].
According to the TGA, the manufacturer 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.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00898-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Oct 2023