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Medtronic Paradigm Mini Med Insulin Infusion Pumps “Urgent Safety Communication”

Medical device manufacturer Medtronic has issued an “Urgent Safety Notification” for infusion sets used with the company’s Paradigm Mini Med Insulin Infusion Pumps. Blocked vents can lead to potentially catastrophic over- or under-delivery of insulin.

On June 7, 2013 Medtronic issued a “Dear Healthcare Professional” (DHCP) letter titled “Urgent Medical Device Safety Notification” warning of the “potential for over or under delivery of insulin if insulin or other fluids contact the inside of the Medtronic Paradigm tubing connectors.”

The letter—directed at both healthcare providers and patients with diabetes and other conditions treated with insulin–recites that “Medtronic Diabetes has become aware of a potential safety issue” associated with fluids coming into contact with “the connector on Medtronic Paradigm infusion sets.”  The letter goes on to advise doctors and patients that:

Exposure of the inside of the tubing 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 hypoglycemia or hyperglycemia, which, in extreme cases, may cause loss of consciousness or death.

The letter also advises that “‘[t]he information in this letter applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps” the list of which can be found at the bottom of the notification.

The infusion sets are small catheters which convey insulin from the pump reservoir into the body through a subcutaneous needle.

Significantly, the potential for over-delivery or under-delivery of insulin due to blocked vents in the infusion sets was well known to Medtronic.  On June 29, 2009 it issued a recall of its Paradigm “Quick Set” infusions sets from “Lot 8” manufactured between December 1, 2007 through June 19, 2009, because of a manufacturing defect in the sets which “may not allow the insulin pump to vent air pressure properly [which] could potentially result in the device delivering too much or too little insulin and may cause serious injury or death.”

While the “Lot 8” recall appears to have been the result of a manufacturing defect and the current warning describes what appears to be a design defect in the infusion sets, both incidents share a common mechanism of action—over- or under-delivery of insulin as a result of blocked vents in the infusion set.

It is apparent that Medtronic received a sufficient number of complaints about this problem to trigger a safety notification alert to all doctors and patients who use it products.


FDA Class 1 recall: Medtronic MiniMed Paradigm Quick-Set Infusion Sets

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