Medical device manufacturer, Baxter Healthcare, has issued a medical device alert concerning its EVO IQ Large Volumetric Pump (LVP) UKI [Product code: ELVP001UKI; All Serial number with software version below V01.04.00.01]
The affected devices were distributed between 07 Mar 2019 and 14 Dec 2020. It is reported that if the operator incorrectly loads the set into the pumping channel at the site of the pumping mechanism and fails to follow the operator's manual and on-screen instructions to confirm that drops are falling in the drip chamber, the pump will display that the infusion is running as normal; however, the set may be occluded by the ribs (at the site of the pumping mechanism) and fluid may not be flowing. There is no alert or alarm to notify the user that the pump is not actually infusing.
According to the manufacturer, operators may continue to safely use the EVO IQ LVP infusion system by following the instructions for use (IFU) within the Operator's Manual and on-screen instructions for correct set loading, and by confirming fluid drops are falling in the IV set drip chamber after initiating the infusion (section 4.4 of the Operator's Manual).
The manufacturer will contact the affected users to determine the correction plan and schedule software upgrade.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 24 December 2020