Sam Brusco, Associate Editor08.03.22
Smiths Medical released an Urgent Medical Device Correction Letter to notify customers about a potential issue concerning specific Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers.
In 2015, the company implemented a design change that widened the hinge/latch assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added it to the H-1000 model.
Smiths Medical became aware that the wider assembly may impact pressure exerted on the IV bag while contained in the pressure chamber, potentially causing decreased flow rate, stopped flow, or residual fluid left in the IV bag.
The affected products were distributed in the U.S. between December 19, 2016 and March 10, 2022, though all Level 1 H-2 Pressure Chamber devices may be affected by this issue, because some devices may have received a hinge/latch replacement during that time.
Products with the wide highe/latch assembly are more susceptible to the issue if there is kinked tubing on the disposable administration sets or use the lowest flow rate disposables (DI-50, D-70, or DI-70) when delivering viscous fluids like chilled blood from 300 mL or smaller IV bags.
Decreased flow rate, stopped flow, or residual fluid left in the IV bag could cause under-delivery or delay of therapy, leading to potential inadvertent hypothermia, hypovolemia, and/or hypotension—which may lead to serious injury and death.
Smiths Medical sent all affected customers and distributors a letter outlining the risk, providing steps to determine whether their device is affected, and steps to follow if the affected product is in service. It can be read here.
In 2015, the company implemented a design change that widened the hinge/latch assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added it to the H-1000 model.
Smiths Medical became aware that the wider assembly may impact pressure exerted on the IV bag while contained in the pressure chamber, potentially causing decreased flow rate, stopped flow, or residual fluid left in the IV bag.
The affected products were distributed in the U.S. between December 19, 2016 and March 10, 2022, though all Level 1 H-2 Pressure Chamber devices may be affected by this issue, because some devices may have received a hinge/latch replacement during that time.
Products with the wide highe/latch assembly are more susceptible to the issue if there is kinked tubing on the disposable administration sets or use the lowest flow rate disposables (DI-50, D-70, or DI-70) when delivering viscous fluids like chilled blood from 300 mL or smaller IV bags.
Decreased flow rate, stopped flow, or residual fluid left in the IV bag could cause under-delivery or delay of therapy, leading to potential inadvertent hypothermia, hypovolemia, and/or hypotension—which may lead to serious injury and death.
Smiths Medical sent all affected customers and distributors a letter outlining the risk, providing steps to determine whether their device is affected, and steps to follow if the affected product is in service. It can be read here.