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

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