| Reason for the Action |
Baxter Healthcare has received reports of under-infusion involving compounded medicines administered via elastomeric infusion devices.
This problem may result in patients receiving less than the prescribed dose of their therapy within the intended infusion timeframe.
Some reports specifically concern a combination of medications used in the EPOCH oncology regimen - Doxorubicin, Etoposide, and Vincristine - which are compounded upon request under an Elastomeric Stability Agreement.
Several factors can influence the flow rate of elastomeric infusion devices, including:
(1) Fill Volume, (2) Temperature, (3) Viscosity of the medication, (4) The difference in height between the Fill Port and the Distal End Luer Lock/Flow Restrictor and (5) Catheter size.
Update 29/09/2025: An update to the IFU to include additional information on factors that may impact flow rate is in-progress. This will be available in 2026.
Meanwhile, Baxter has implemented the following measures to support customers with additional guidance on factors that may impact flow rate:
·Updated Elastomeric Products Professional Guide
·Updated Elastomeric Patient Guide and Elastomeric Mini Patient User Guide. |