Safety notice for Medtronic Paradigm IPC
Medtronic after consultation with the TGA (TGA Ref# RC-2013-RN-00587-1), is initiating a voluntary "Recall for Product Notification" for the above mentioned devices.
The purpose of this letter is to notify you that Medtronic Diabetes has become aware of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the connector on Medtronic Paradigm infusion sets. This letter also provides information that will allow you to prevent this from occurring.
Note: There is no action required on your part apart from returning the completed acknowledgement of receipt for the notification.
Exposure of the inside of the infusion set connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin. If this occurs, the insulin can temporarily block the vents in the connector that allow the pump to properly prime. If these vents are blocked, this can potentially result in too much or too little insulin being delivered, which may cause hypoglycaemia or hyperglycaemia, which, in extreme cases, may cause loss of consciousness or death.
The information in this letter applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps. The specific model numbers affected are 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.
Please note that the potential for temporary blocking of the infusion set vents can be avoided by not allowing liquid to make contact with the inside of the tubing connector and following the recommended reservoir filling procedure with careful attention to the information provided below.
To prevent fluid from blocking the connector vents:
1. After filling the reservoir, 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.
2. If any liquid (such as insulin, isopropyl alcohol, or water) gets on the top of the reservoir or inside the tubing connector, start over with a new reservoir and infusion set.
How to recognise that the infusion set vents may be blocked
If you notice anything unusual during the infusion set prime process such as the insulin continuing to drip from the infusion set cannula when the manual prime has been completed, this may indicate that the connector vents are not working properly. If this occurs, do not insert the infusion set and call the Helpline immediately for additional assistance.
In addition to providing this communication to current users of Medtronic Paradigm insulin pumps, Medtronic are also updating the instructions for use to include this information on how to avoid temporary blocking of the infusion set vent membranes due to exposure to fluid.
Medtronic have notified your healthcare professional about this potential safety issue and are there to assist you with any questions or concerns you may have. Please feel free to contact their 24 Hour Helpline at 1800 777 808, option 1, if you would like more information.