Updated with comment from Repro-Med Systems
The FDA today released a warning letter it sent to Repro-Med Systems over issues it found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps.
The letter was in response to an earlier reply from Repro-Med, which the FDA said was “not adequate” for handling the issues it raised, as well as laying out several aspects of the devices that were being mis-marketed, as well as failures in quality control and medical device reporting.
Repro Med Systems said it is aware of the items which require additional clarification, and that it is in the process of addressing those issues and providing the documentation necessary.
“While we anticipate one item taking a bit longer to resolve, the others are merely an exercise in better communicating our thorough processes and premium safety standards to the FDA,” RMS chief medical officer Dr. Fred Ma said in a press release.
In the response letter, the federal watchdog said that the company’s Freedom 60 syringe and Freedom Edge infusion pumps were misbranded due to modifications made to the system.
The agency referenced specific modifications to the Freedom 60 syringe pump that could “affect safety and effectiveness.” The FDA reported that the company changed the pressure specification range from 13 psi max to 15 psi max and shifted the flow rate specification range from 1 – 500 ml/hr to 0.5 – 2400 ml/hr.
The federal watchdog said Repro-Med also developed and marketed a different version of the pump, the Freedom Edge infusion pump, which uses a different syringe volume, pumping mechanism and mode of operation, without proper clearance.
The company was hit for promoting the device outside its indications after promoting the product for the infusion of “prescribed liquid medicines” which the FDA said are only cleared of IV infusions.
In a similar case, the FDA noted that Repro-Med was marketing its RMS HigH-Flo subcutaneous safety needle sets for indications outside their intended use. The federal watchdog said the that Repro-Med’s consumer brochure for the product indicated it for subcutaneous immunoglobin infusion, which was not cleared by the agency.
Quality system violations, including a failure to conduct a flow profile study for its precision flow tubing, failures to conduct design verification activities, verification protocols and other points were referenced by the FDA.
Repro-Med was also hit for a failure to establish and maintain design and development plans, failure to establish routine calibration, inspection and maintenance procedures, a failure to maintain retesting and revaluation of nonconforming products, a failure to establish corrective and preventive actions for its supplier and a failure to maintain acceptance activities.
The FDA laid out a handful of specific medical device reporting violations, calling out the company on failing to “establish internal systems that provide for timely and effective identification, communication and evaluation of events,” as well as 3 other specific problems.
Repro-Med was given the usual 15 business days to respond to the letter, with the threat of “seizure, injunction, and civil money penalties” if the violations are not corrected.