The FDA has notified healthcare professionals of a Class I recall of the Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System drug library kit.
Class I is the most serious type of recall and indicates “a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
In the recalled product, the Dose Error Reduction System potentially gives an incorrect recommended value for the pump infusion rate during the initial infusion setup, due to a specific key sequence when the override feature of the DERS drug limits is activated. A device malfunction can result in an increased risk of over-infusion or under-infusion if the infusion is started with this rate value.
These products were manufactured from Oct. 1, 2011 through June 27, 2013 and distributed from Oct. 6, 2011 through June 28, 2013. The MRidium 3860+ Infusion pumps are intended for general hospital or clinical use by medical professionals whenever intravenous or intra-arterial infusion before, during or after MRI scans is required. The MRidium 1145 Dose Reduction System drug library kit is an accessory intended for use with the MRidium 3860+ Infusion Pump System.
Iradimed Corporation notified its customers by phone, and on July 1 sent an “urgent medical device recall notice” to all customers, instructing them to identify the MRidium 3860+ Infusion Pumps that have the 1145 DERS Library Card (AM05) installed. If these are not installed, no further action is required. However, if the DERS Library Card is installed, customers should remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided in the notice.
The product will be repaired by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be seen during the 3860+ Pumps power on cycle.
Refer to the FDA recall notice for more information and a listing of affected part numbers: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm364659.htm.