Iradimed Begins Class I Recall of Infusion Systems

By Jim Dickinson

The MRidium 3860+ Infusion System can potentially recommend incorrect infusion rates.

Iradimed Corp. has begun a Class I recall of its MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit due to the potential for incorrect recommended infusion rate.

“The Dose Error Reduction System (DERS) can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup,” a recall notice says. “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.”
 
The infusion pumps are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with fluids or medications before, during or after Magnetic Resonance Imagining scans. The recall notice says affected products will be repaired (reconditioned) by installing a software upgrade that corrects the problem.
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