Medical device manufacturer, Baxter, has issued a field safety notice concerning EXACTAMIX Compounders with model numbers 2400-DY and 1200-DY.
The EXACTAMIX Compounder uses a Universal Ingredient (UI) to flush the common fluid pathway at the end of compounding activities. If the UI in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual, a flush of the outlet pump tube will not be initiated by the software. As a result, the original UI may remain in the tube and could be delivered into the next bag.
This could lead to an over delivery of the first UI, an under delivery of the subsequent UI, or a delivery of an unintended UI. Drug incompatibilities or drug-drug interactions are not reasonably expected with this issue because the UIs are normally sterile water for injection, dextrose 50% and dextrose 70%. The worst case scenario would be an unintended rapid infusion of 13.7g of dextrose into a diabetic patient causing hyperglycemia, which may require medical intervention.
The manufacturer is updating the EM2400 and EMI200 Operator Manuals to provide further clarification – "The Configuration Editor is to be used only to create and manage non-active configurations. All changes to the UI of an active configuration must be made through the "Change UI" functionality described."
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 17 Jul 2014