The FDA today released a medical device safety communication warning of air-in-line and air embolism risks, as well as the risks of false alarms for such events, with infusion pumps, fluid warmers and rapid infusers.
The FDA reinforced the dangers of air-in-line issues, which can lead to potentially life-threatening air embolisms, but also warned of the risks associated with false alarms triggered by air-in-line sensors. Such false alarms could lead to injury due to the possible interruption of infusion therapy, which “could be problematic if crucial medications (for example, Epinephrine) are being infused,” according to the release.
The federal watchdog said that from January 2016 to December 2018, approximately 3% of all Medical Device Reports it received were associated with air-in-line issues with infusion pumps, rapid infusers, fluid warmers and accessories.
The agency said that the majority of the reports were due to malfunctions with air-in-line alarms or error messages which did not cause patient injuries, but added that a small number indicated delays in critical medication therapy or potential air embolisms and possible patient deaths.
The issues were not specific to any manufacturer or particular device models, the FDA said, who warned that limited information in the reports and the presence of comorbidities make it unclear if “correlation exists between the infusion pump, rapid infuser, build warmer or their accessories and patient outcomes.”
The agency recommended that healthcare professionals using the device appropriately plan ahead before use, including having a backup and monitor, as well as a number of other steps intended to mitigate risk.