Medtronic Paradigm Tubing Connectors
important medical device safety information
Here at Medtronic, we’re committed to keeping our customers informed of issues and solutions concerning our products and services. That is why we’re notifying all global Paradigm customers and healthcare professionals to advise them of a potential safety issue that has been identified.
While changing an infusion set, if insulin, or any liquid, gets on the inside of the tubing connector on Paradigm infusion sets, it can temporarily block the vents that allow the pump to properly prime. We are discussing this issue with our customers because it can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia.
No products need to be returned as a result of this communication. Because the safety of customers is our top priority, we are providing our customers important information about the reservoir fill process as outlined in your training materials. It’s important to note that when the reservoir fill process and priming procedures are followed according to the instructions, the Paradigm reservoirs and infusion sets in the Paradigm pumps should work as they are supposed to.
If you have questions relating to this issue, we encourage you to talk with your healthcare professional or contact us 24 hours-a-day at 1-888-204-7616.
Below you’ll find a video demonstrating the reservoir fill process for your Paradigm® Revel™ insulin pump. Please pay particular attention to make sure the vial of insulin is held upright when removing the reservoir from the blue transfer guard. (This prevents insulin from accidentally getting on the top of the reservoir, which could transfer liquid into the tubing connector.) If any liquid gets on the top of the reservoir or inside the tubing connector, please be sure to start over with a new reservoir and infusion set.
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