• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA warns on air embolism risk with infusion pumps, fluid warmers, rapid infusers

January 31, 2019 By Fink Densford

air embolism

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.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS