An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient as part of intensive insulin therapy.
The patient attaches a reservoir of insulin to the infusion set and then connects one end of the infusion set to the pump. At the other end of the infusion set is a flexible plastic cannula or a steel needle, which is inserted into the skin by hand or via an insertion device. The infusion set must be primed, meaning the pump pushes insulin quickly through the tubing and cannula to purge air from the infusion set, before inserting the cannula or needle into the skin or the patient may receive an accidental delivery of a large dose of insulin.
The infusion set is usually replaced by the patient every two or three days.
On June 29, 2009, the U.S. Food and Drug Administration (FDA) issued a Class I recall of specific lots of Quick-Set Infusion Sets manufactured by Medtronic, Inc. for use with MiniMed Paradigm insulin pumps. The recall affected about 60,000 infusion sets.
These recalled infusion sets may not have allowed the insulin pump to vent air pressure properly. This defective medical device may have delivered too much or too little insulin to the patient and caused serious injury or death.
Class I recalls are the most serious type of recall issued by the FDA and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Recalled were Models MMT-396, MMT-397, MMT-398, and MMT-399 (with lot numbers beginning with "8," for example 8XXXXXX) Paradigm Quick-Set Infusion Sets. The lot number was marked on both the product label, and on each individual infusion set package. Only "Lot 8" Paradigm Quick-set infusion sets were affected by the recall.
Medtronic voluntarily recalled these specific infusion sets, sending letters to patients and customers to advise them to stop using the recalled infusion sets, confirm receipt of the recall notice, return unused sets to Medtronic and to order replacement sets.
Medtronic also issued letters to distributors who purchased the affected devices notifying them to stop distributing the affected product, to inform all patients they have provided infusion sets of the recall or to provide patient names and addresses to Medtronic so the company could inform the patients.
If you or a loved one suffered injury or a loved one died due to improper insulin dosage delivered by a Paradigm Quick-Set Infusion Set, you may be entitled to compensation for your injury, a loved one's injury or wrongful death. Do not dispose of or return recalled Paradigm Quick-Set Infusion Sets to the manufacturer if a serious or fatal injury has occurred.
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