Paradigm Tubing Connectors

Product and Service Updates

 

Medtronic Paradigm® Tubing connectors

Date 6-10-2013
Download important safety information for Paradigm® tubing connectors Download >

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 insulin 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.

Paradigm® RevelTM Insulin Pump Infusion Set Video Quick Reference Guide
quick set Quick-set® Play
silhouette Silhouette® Play
mio mio® Play
sure-t Sure-T® Play
MiniMed Paradigm® 522/722 Insulin Pump Infusion Set Quick Reference Guide
quick set Quick-set®
silhouette Silhouette®
mio mio®
sure-t Sure-T®
FAQs
Q:
I didn’t get a letter from Medtronic. Was I supposed to? >
A:
We are sending letters to all of our Medtronic Paradigm customers as well as healthcare professionals and distributors. If you haven’t received a letter yet, you can view the full message here
Q:
I received the letter and I am concerned about my infusion sets. What do I do? >
A:
Since your safety is our number one priority, we work hard to keep you informed of potential issues. In this case, we wanted to make sure that you understand the importance of following the instructions on how to fill your reservoir. 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.

Please refer to the letter you received for important information about filling the reservoir.

Q:
What does it mean when the vent is temporarily blocked? What could happen to me if the vent gets blocked? >
A:
When changing an infusion set, if 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.
Q:
Where is the vent on the tubing connector located? >
A:
There are four small vents that are located on the tubing connector that attaches onto the reservoir. You can see them if you look at the top of the tubing connector, on the side where the tubing comes out, or if you look on the underside where the tubing connector connects to the reservoir.
Q:
Why do Paradigm infusion sets have vents? >
A:
The vents allow the chamber to equilibrate while protecting the inside of the pump from water. This notification explains the importance of keeping the inside of the tubing connector dry, so that the vents function as designed.
Q:
Will Medtronic be replacing all infusion sets currently in the marketplace? >
A:
There’s no need for your product to be replaced as a result of this communication. As long as liquid does not get on the inside of the tubing connector, your infusion set should work as it’s supposed to. We are reminding customers of the instructions for filling their reservoir, and asking them to pay particular attention to making sure the vial of insulin is held upright when removing the reservoir from the blue transfer guard. If you do see any liquid on the top of the reservoir or inside of the tubing connector, be sure to start over with a new reservoir and infusion set. And, as always, if you notice anything unusual about the prime process, do not insert the infusion set. Call our 24-Hour HelpLine for support.
Q:
Which Infusion Sets Does this Temporary Vent Blockage affect? >
A:
This field notification involves all Paradigm infusion sets, including the Quick-set, Silhouette, Sure-T, Mio, Polyfin, and Sof-set. If needed: This field notification involves MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm infusion sets.
Q:
Are my infusion sets safe to use? >
A:
Yes. The use of the Paradigm reservoirs and infusion sets in the Paradigm pumps should work as they are supposed to when the reservoir fill process and priming procedures are followed according to the instructions. Since your safety is our number one priority, we work hard to keep you informed of potential issues. In this case, we wanted to make sure that you understand the importance of following the instructions on how to fill your reservoir. As long as liquid does not get on the inside of the tubing connector, you don’t need to be concerned about this issue. (Refer to instructions in the letter as needed.)
Q:
What are you doing to fix these potential issues? >
A:
Since your safety is our number one priority, we work hard to keep you informed of potential issues. We are notifying you to remind you about this important information about the reservoir fill process, which includes holding the insulin vial upright when you remove the reservoir, and avoiding getting the top of the reservoir and inside of the tubing connector wet. 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 insulin pumps should work as they are supposed to.
Q:
Is Medtronic contacting my doctor about this? >
A:
Yes, we are notifying your doctor about this important information.