Sam Brusco, Associate Editor02.27.23
iRadimed sent out an Urgent Medical Device Correction letter to inform affected customers about a possible issue with some of its 1057 syringe adapter sets related to syringe venting function during use. This can cause reduced flow with the MRidium infusion pump, leading to inlet occlusion and alarm indication.
The 1057 syringe adapter is an IV fluid administration set with a vented syringe adapter—disposable tubing—to deliver IV fluids from syringes while on the company’s infusion pump.
The customer notification includes associated risks, lists affected products, and provides updated labeling about actions to take to identify venting and infusion delivery problems before an inlet occlusion happens.
According to a press release, iRadimed received five customer complaints about an unexpected inlet occlusion alarm, which caused infusion to be stopped. None of the complaints were associated with injury or death. After investigation, the company identified a defective injection molded part that can limit the syringe vent’s effectiveness.
The condition was estimated by the company to be in 0.4% of infusion sets.
The 1057 syringe adapter is an IV fluid administration set with a vented syringe adapter—disposable tubing—to deliver IV fluids from syringes while on the company’s infusion pump.
The customer notification includes associated risks, lists affected products, and provides updated labeling about actions to take to identify venting and infusion delivery problems before an inlet occlusion happens.
According to a press release, iRadimed received five customer complaints about an unexpected inlet occlusion alarm, which caused infusion to be stopped. None of the complaints were associated with injury or death. After investigation, the company identified a defective injection molded part that can limit the syringe vent’s effectiveness.
The condition was estimated by the company to be in 0.4% of infusion sets.