MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump Sys

FDA device recall Z-1874-2013 · posted 2013-08-02 · Terminated

Recall details

Recalling firm

Iradimed Corporation

Reason for recall

The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.

Action taken

The firm, Iradimed Corporation, notified by phone and sent an "URGENT MEDICAL DEVICE RECALL NOTICE" via email dated July 1, 2013 all consignees/customers. The notice described the product, problem and action to be taken. The customers were instructed to identify the MRidium 3860+ MR Infusion Pumps which have the 1145 DERS Library card (AM05) installed. If these are not installed, no further action is required at this time; however, if they are installed-remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided. Product will be reconditioned by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be seen during the 3860+ Pump's power on cycle. Should your users have any questions following these instructions, please contact Iradimed Customer Service; 866-677-8022 (toll free) or 407-677-8022 ext. 100 or via e-mail - recallsupport@iradimed.com

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

FRN

Quantity affected

176 individuals kits

Distribution

Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denma

Date initiated

2013-07-01

Date posted

2013-08-02

Date terminated

2015-07-13

Location

Winter Park, FL

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