Immediate actions for health services
The enFlow fluid warming system disposable cartridge has been recalled by the TGA.
If your service is using an enFlow fluid warmer with disposable cartridges (980200EU and 980202EU), please:
- use an alternative fluid warming device if available
- consider other methods of warming patients at risk of hypothermia, e.g. use forced air warmers.
Please contact us immediately if:
- you do not have an alternative device
- you have not been contacted by the TGA or manufacturer Vyaire.
Please note, there are currently no suitable alternative cartridges for enFlow Devices.
The enFlow fluid warming device is used to warm fluids and blood before they are infused into patients during surgery.
The most common clinical areas these devices are used are in operating theatres, intensive care units and emergency departments.
Victoria has now received correspondence about the issue from the TGA. A recent journal article published in Anaesthesia found that enFlow fluid warming devices, which use an uncoated disposable aluminium heating plate, can leak high concentrations of aluminium into intravenous infusion fluids.
This can lead to aluminium toxicity which is associated with a large range of diseases, including microcytic anaemia and encephalopathy.
Risk of aluminium toxicity
Patients at highest risk of aluminium toxicity are the elderly, children and patients with renal impairment or who have repeated exposure.
It is widely accepted that the recommended threshold for aluminium levels in parenteral and enteral nutrition is 25 μg per litre.
Testing of the enFlow devices found:
- aluminium levels of between 3400 and 8000 μg per litre when using an electrolyte solution
- these concentration levels drop significantly when using a saline solution, to less than 128 μg per litre.
Clinical experts have advised that high aluminium levels may not be adequately excreted via renal systems and can have a long half-life if deposited in tissues.
SCV is not aware of any patient harm in Victoria due the use of this device.