Pharmaceutical

Medtronic issues urgent medical device safety notice regarding infusion pumps

black box warning graphic WL Medtronic issues urgent medical device safety notice regarding infusion pumpsMedtronic has issued an urgent medical device safety notification to patients and health care providers regarding its Paradigm Infusion Set Connectors, which connect to Medtronic Paradigm infusion sets used to administer insulin to diabetic patients in order to maintain blood glucose levels. Vents can become blocked if insulin or other fluids come in contact with the inside of the connector on the Medtronic Paradigm infusion sets.

If the pump’s vents are blocked, this can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia. In extreme cases, these conditions may cause loss of consciousness or death.

According to the safety notification, exposure of the inside of the infusion set connector to fluid is most likely to occur if insulin is spilled on 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. The safety notice provides information to help prevent this problem from happening.

Patients who use Medtronic Paradigm infusion should be aware of anything unusual during the infusion set prime process, such as the insulin continuing to drop from the infusion set cannula when priming has been completed. This may indicate that the connector vents are not working properly. If this occurs, patients are advised not to insert the infusion set and call the HelpLine at 888-204-7616 immediately for additional assistance.

Any adverse events or quality issues with this medical device should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA