The Medicines and Healthcare products Regulatory Agency (MHRA) have today issued a Medical Devices Alert (MDA) about the enFlow IV Fluid/Blood Warming System, manufactured by Vyaire.
The intended use of the enFlow IV Fluid/Blood Warming System is for warming blood, blood products and intravenous solutions prior to administration. It is designed to be used by healthcare professionals in the hospital, clinical and field environments to help prevent hypothermia. The system consists of the enFlow heating system and the disposable cartridge.
The issue with the device relates to a recent paper published by the journal of Anaesthesia, which concluded that uncoated aluminium plates in fluid warming systems can lead to a risk of administering potentially harmful concentrations of aluminium, when using balanced electrolyte solutions.
Please refer to the MDA and Field Safety Notice (FSN) for background information and recommended action.
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