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

Drug Delivery Business

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

Smiths Medical warns on potential issue with fluid warmers

August 3, 2022 By Sean Whooley

Smiths MedicalSmiths Medical announced today that it issued an urgent medical device correction letter regarding its Level 1 Fast Flow fluid warmers.

Minneapolis-based Smiths Medical’s Level 1 H-2 pressure chambers used with the Level 1 Fast Flow fluid warmers could potentially impact the pressure exerted onto an IV fluid bag while contained within the pressure chamber, potentially resulting in decreased flow rate, stopped flow or residual fluid left within the IV bag.

Such incidents could result in the under-delivery or delay of therapy, leading to potential inadvertent hypothermia, hypovolemia, and/or hypotension which may lead to serious injury and death.

According to a news release, the company in 2015 implemented a design change to widen the hinge/latch assembly on the devices (Models H-1025 or H-1200) or added it to the H-1000 model. The pressure chambers with this wider hinge/latch assembly are the affected devices.

Smiths Medical said the affected product was distributed in the United States between Dec. 19, 2016, and March 10, 2022.  However, all Level 1 H-2 Pressure Chamber devices have the potential to be affected by this issue, because some devices may have received a hinge/latch replacement during that timeframe.

Level 1 H-2 Pressure chambers with the wide hinge/latch assembly are more susceptible to this issue in scenarios including kinked tubing on the disposable administration sets and use of the lowest flow rate disposables (DI-50, D-70 or DI-70) when delivering viscous fluids.

Smiths Medical sent all affected customers and distributors a letter outlining the risk and providing the proper steps to follow to determine whether devices are affected, plus what steps to follow if there is an affected product in service.

Filed Under: Auto-injectors, Drug-Device Combinations, Recalls Tagged With: Smiths Medical

IN CASE YOU MISSED IT

  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling
  • Senseonics stock is up as it sticks by revenue guidance
  • Rapid Dose closes first tranche of $5M financing

Primary Sidebar

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.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

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
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS