MRidium Infusion System Recall Issued Due to Malfunction Risk

A Class I recall has been initiated for Iramed Corporation infusion systems, due to problems where the software program may recommend dosages to the patients that are too high or too low, posing a risk of serious and potentially life-threatening adverse health consequences.  

The MRidium 3860+ Infusion pump recall was issued after the manufacturer recognized the safety program “Dose Error Reduction System” (DERS), within the pumps may fail to recommend the proper amount of medication to be administered during the initial infusion setup.

If the incorrect amount recommended is given to the patient it may result in an over or under-infusion which can lead to serious harm for patients. As a result of the reasonable probability that continued use of the product may cause injury or death, the FDA has categorized the action as a Class I recall this week, which is the most serious form of medical device recall.

The recalled MRidium 3860+ Infusion systems are intended for general hospital or clinical use by healthcare professionals to administer fluids or medications to patients intravenously or through arteries before, during, or after Magnetic Resonance Imaging, commonly called MRI’s. The company sent out an Urgent Medical Device Recall Notice (PDF) on July 1.

The recall consists of only the MRidium 3860 Infusion Systems equipped with MRidium 1145 Dose Error Reduction System Drug Library Kit. The recalled systems have part number 1145 and contains the following lot numbers included in the recall; 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.

The affected infusion pumps were manufactured by Iradimed Corporation of Winter Park, Florida from October 1, 2011 through June 27, 2013 and distributed from October 6, 2001 through June 28, 2013 to healthcare professionals nationwide.

Customers should check to see if they are in possession of a the MRidium 3860 Infusion Systems equipped with MRidium 1145 Dose Error Reduction System Drug Library card. Customers should immediately remove 1145 DERS Library card from the pump using the instruction manuals provided in the urgent medical device recall notice.

Customers with affected infusion systems should contact Iradimed Corp at 1-866-677-8022 or by email at recallsupport@iradimed.com to set up a repair of the 1145DERS Library Card by installing new software to prevent the problem.