IRadimed Corp. issued an Urgent Medical Device Correction Letter to notify affected customers of a potential issue with some 1057 Syringe Adapter Sets related to the syringe venting function during use which can lead to reduced flow with the MRidium infusion pump resulting in subsequent inlet occlusion and alarm indication.
The 1057 Syringe Adapter Set is a unique IV fluid administration set with a vented syringe adapter (disposable tubing), which allows for the delivery of IV fluids from syringes while on the company’s infusion pump. The customer notification, which outlines the potential risks associated with the 1057 Syringe Adapter Set, lists the affected products, and the updated labeling provides specific actions users should take to identify any venting and infusion delivery issues before an unexpected inlet occlusion occurs.
IRadimed received five customer complaints of an unexpected inlet occlusion alarm resulting in the infusion being stopped, none of which were associated with injuries or death. Upon investigation, the company identified a defective injection molded part that can limit the effectiveness of the syringe vent and result in this condition in an estimated 0.4% of recently manufactured 1057 infusion sets.
This action was taken voluntarily to maximize the safety of the device’s use and with the knowledge of the FDA. No other of the company’s IV sets or disposables are involved, and the company does not expect any material financial impact from this action.
IRadimed Corp. is a provider in developing MRI compatible medical devices. The company designs, manufactures, markets, and distributes MRI-compatible medical devices, accessories, disposables, and related services.