Class l Iradimed Corporation Infusion Systems

Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit
Company: Iradimed Corporation
Date of Enforcement Report: 8/12/13
Date Recall Initiated: 7/1/2013
Class l:

PRODUCT
MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
Recall Number Z-1874-2013

REASON
The Dose Error Reduction System (DERS) can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup. This is 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. This can cause serious adverse health consequences, including death.

RECALLING FIRM/MANUFACTURER
Recalling firm: Iradimed Corporation, Winter Park, FL on 7/1/2013. Voluntary, firm-initiated reacll is ongoing

VOLUME OF PRODUCT IN COMMERCE
176 individuals kits

DISTRIBUTION
Nationwide and Internationally

FDA District

Florida District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.