Smiths Medical, 3012307300-06222022-004-C, Level 1 H-2 Pressure Chambers

Smiths Medical implemented a design change to widen the hinge 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 to the H-1000 model. Smiths Medical has become aware that Level 1 H-2 Pressure Chambers with the wider hinge assembly can potentially impact the amount of pressure exerted onto the IV fluid bag while contained within the pressure chamber. This may result in decreased flow rate, stopped flow or residual fluid left within the IV bag.

Decreased flow rate, stopped flow or residual fluid left within the IV bag could potentially result in under-delivery or delay of therapy leading to potential inadvertent hypothermia, hypovolemia, and/or hypotension. To date, Smiths Medical has received three (3) reports of deaths and sixty-four (64) reports of serious injuries potentially related to this issue.
In addition to the risk described above, the following outstanding risk described in the Field Safety Notice issued October 06, 2021, regarding the potential for aluminum leaching remain: Exposure to toxic levels of aluminum could potentially lead to serious injury or possibly death, depending on the treatment being administered and the patient’s condition. Symptoms of toxic levels of aluminum exposure may not be readily recognizable and exposure effects may vary including bone or muscle pain and weakness, anemia, seizures, or coma.