iRadimed (Nasadq:IRMD) issued an urgent medical device correction letter to warn of issues with some infusion pump syringe adapter sets.
The letter notifies customers of a potential issue with some 1057 Syringe Adapter Sets. The issue relates to the syringe venting function during use. This can lead to reduced flow with the MRidium infusion pump, resulting in subsequent inlet occlusion and alarm indication.
Winter Springs, Florida-based iRadimed designed the adapter set as a unique IV fluid administration set. It features a vented syringe adapter (disposable tubing) for fluid delivery while on iRadimed’s infusion pump.
The company received five customer complaints of an unexpected inlet occlusion alarm resulting in stopped infusion. None of these complaints were associated with injuries or death, according to a news release. iRadimed investigated the issue and uncovered a defective injection molded part. This defective part can limit the effectiveness of the syringe vent and result in this condition.
iRadimed estimates that the issue affects 0.4% of recently manufacture 1057 infusion sets. The company took voluntary action to maximize the safety of the device’s use with the knowledge of the FDA. It affects no other iRadimed infusion sets or disposables. The company expects no material financial impact from its voluntary action.