Diabetes infusion pumps recalled due to dangerous defect

diabetes illus250x03 Diabetes infusion pumps recalled due to dangerous defectAnimas 2020 Insulin Pumps manufactured between March 1, 2012 and November 30, 2012, are being recalled because the devices have a defective component that may trigger the pumps to sound a false alarm or warning. The pumps are used to deliver insulin directly into the blood of diabetics. The recall is categorized as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that using the products will cause serious adverse health consequences or death.

The defect may signal the pump to warn of one of the following: “Loss of Prime,” “Occlusion,” or “No Cartridge Detected.” If the device issues one of these false alarms, it may prompt users to complete the rewind, load and prime sequence to clear the alarm. Failure to follow the pump’s safety instructions and disconnect the infusion set from the body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing the patient in danger of serious health risks, such as hypoglycemia.

People who have this device should read the safety instructions in the Animas Owner’s Booklet and ALWAYS disconnect the infusion set from the body before performing any of the “rewind, load and prime” steps.

The Animus Infusion Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no longer deliver insulin and will generate a “Call Service Alarm” message.

Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of a free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253.

Source: FDA