Iradimed Warned Over CAPAs, Procedures

September 17, 2014

The FDA has warned Winter Park, Fla., devicemaker Iradimed for failing to initiate and validate corrective actions related to its infusion pumps and sets.

Among the concerns cited by the agency, the company had recalled some of its infusion sets after finding a tubing segment was too long, which could cause them to over-infuse, and traced the root cause to production process controls at its contract manufacturer. However, Iradimed did not verify or validate the effectiveness of its corrective action, according to the Aug. 18 letter published Tuesday.

Meanwhile, the company received at least 18 complaints between 2010 and August 2012 for possible over-infusions with MRI infusion pumps. After determining the likely root cause was user error, the company sent a Safety Alert Letter to customers. However, the FDA says the corrective actions “were not effective” as Iradimed has received nine similar complaints since Sept. 18, 2012.

Another citation notes that Iradimed did not assess the potential risk of tubing used with its MRI infusion pumps being stretched during removal of bubbles or other activities. This can cause improper positioning and over-infusion, the letter says. The warning letter followed an April 7-16 inspection of Iradimed’s Florida facility.

Procedural Problems

The letter goes on to discuss a number of procedural problems. For example, Iradimed’s Software Quality Assurance Procedure states that validation should be conducted based on the “level of concern” for infusion pump software; however, it doesn’t address how to set the level of concern or establish validation plans appropriate for the level.

The same procedure advises creation of a traceability analysis or matrix to connect requirements, design, specification, hazards and validation, but no traceability analyses were documented for multiple software versions for the Mridium 3860 and 3850 models, the letter says.

The FDA also found fault with Iradimed’s employee training procedure. Although the procedure requires that areas of training be identified by each department, during the inspection, the company could not show documentation that training needs for software engineers regarding coding practices are routinely identified. Iradimed told the FDA investigator that it did not have specific training needs for software engineers, the letter says.

The FDA also chides the company for misbranding its Model 3860 and 3850 MRI infusion pumps by modifying the original software without obtaining a new 510(k). The agency advised Iradimed to stop commercial distribution of the devices, along with the Mridium 3860+ infusion pump, which lacks regulatory clearance or approval.

Iradimed did not respond to a request for comment by press time. View the warning letter at www.fdanews.com/ext/resources/files/09-14/09-02-14-Iradimed.pdf. — April Hollis