Smiths 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.
