Product Defect Alert: Pressure Plates used in Level 1 Fast Fluid Flow Fluid Warmers

A product defect alert has been issued for the Level 1 H-2 Pressure Chamber (Model number: 7204012, Serial Numbers: 44000448 to 44006780) manufactured by Smiths Medical, which is used with the Level 1 Fast Flow Fluid Warmer (Models H-1025 or H-1200) or added to the H-1000 model.

A change to the hinge design on the pressure chamber has created a risk of varying pressure being applied to the IV bag, potentially causing decreased flow rate, stopped flow or residual fluid left behind in the bag. This may cause under-delivery or delay of therapy to the patient, with possible consequences including hypothermia, hypovolemia, and/or hypotension. Three reports of death and sixty-four of serious injury have been received.

The manufacturer has written to impacted users instructing them to identify affected devices and undertake the temporary corrective actions described in the letter. A replacement kit for part of the device will be distributed in due course.

For more information, please refer to the Therapeutic Goods Administration Australia listing or the Medsafe New Zealand listing.