Medical device manufacturer, Baxter Healthcare SA has issued a medical device safety alert concerning INFUSOR Portable Elastomeric Infusion System with product codes 2C1071KJP, 2C1075KJP and 2C1976KJ. All lot numbers within expiration dating are affected.
While there have been no changes made to the product, recent review of flow rate testing has shown that the nominal flow rate as labelled is achieved when the Elastomeric Reservoir is positioned 6-8 inches (15-20 cm) below the distal Luer lock and not when positioned at the same height as stated in the Directions for Use. If the device is positioned according to the current Directions for Use, a greater than intended flow rate (up to 4%) may occur.
Therefore, the manufacturer now advises users to position the infusion system's Elastomeric Reservoir 6-8 inches (15-20 cm) below the distal Luer lock in order to achieve the labelled flow rate.
According to the local supplier, the affected products were distributed to Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 March 2014