ICU Medical’s Smiths Medical this week issued an urgent field safety notice for some of its Portex Blue Line siliconized PVC tracheotomy tubes.
The company issued the warning due to an issue related to the neck plate or flange of the Portex Blue Line siliconized PVC tracheotomy tubes. The failure mode can happen during use as a complete or partial detachment of the neck plate from the tracheostomy tube on Portex Blue Line Classic tracheotomy tubes.
If the failure mode occurs, a patient could receive inadequate ventilation and complete dislodgement of the tracheostomy tube. The company said in the warning letter that hypoxia, underdose, cardiopulmonary collapse, bradycardia, hypotension, respiratory arrest, or asphyxia could result from partial or complete detachment of the flange.
Smiths Medical has received five reports of serious injury and no reports of death from this issue.