The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, has issued a medical device safety alert concerning the enFlow Disposable Cartridges associated with the enFlow fluid warming system, manufactured by Vyaire Medical. The affected products are identified as follow:

• A) enFlow Disposable Cartridge; B) enFlow Disposable Cartridge with IV Extension Set
• Vyaire Part Number: A) 980200EU; B) 980202EU
• enFlow Fluid Warming System Part Number: 980105VS

A recent paper published by the journal of Anaesthesia 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. [https://onlinelibrary.wiley.com/doi/full/10.1111/anae.14601]

A Field Safety Corrective Action has been initiated by the manufacturer of the affected products due to concerns raised regarding the potential risk of aluminium exposure to patients.

According to the MHRA, following comprehensive and continuing investigation, it is alerting healthcare professionals (HCPs) who use, maintain or are involved in purchasing these medical devices and their local and national healthcare organisations.

To date no adverse incident reports associated with this issue have been received and operators are encouraged to report any suspected adverse events related to any type of these devices to MHRA.

The manufacturer is not aware of a single incident related to the affected products in a clinical setting where aluminum was observed to have been transmitted to a patient in amounts above scientifically-recognized safe limits, nor have there been any reported adverse events related to aluminum exposure.

The manufacturer has issued a field safety notice (FSN) to all customers globally. It is recommending that customers discontinue the use of the enFlow Cartridges. To ensure patients receive this much needed therapy, the manufacturer recommends utilizing an alternate fluid warming device until the investigation into the potential patient safety risk can be thoroughly investigated. If no alternative is available, the manufacturer recommends that the affected users carry out and document a local risk assessment based on a clinical risk-benefit analysis before using these devices.

The manufacturer is providing the following guidance to the affected customers who are unable to transition to an alternative fluid warming system, to follow the instructions below:

• Only use with Normal Saline.
• Do not use the Disposable Cartridge for more than 24 hours.
• Limit enFlow cartridge use to not more than 3 cartridges per single-patient use, with a duration of use up to 24 hours for a maximum duration of device usage up to 72 hours.
• Observe the enFlow Instructions for Use, which note that the disposable cartridge contains aluminium, and that users should review the preparation or solution manufacturer's instructions for use about chemical sensitivity.

MHRA are investigating whether other devices on the market also release higher than recommended levels of aluminium and will take action where necessary.

MHRA advises the HCPs to take the following actions:

• Use an alternative fluid warming device if available.
• If alternatives are available, quarantine affected devices as per the manufacturer's FSN.
• If no alternative is available, carry out and document a local risk assessment based on a clinical risk-benefit analysis before using the fluid warmer. Overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release.

According to the local supplier, the affected products are distributed in Hong Kong

For details, please refer to the following MHRA website:
https://www.gov.uk/drug-device-alerts/enflow-iv-fluid-and-blood-warmer-risk-of-unsafe-levels-of-aluminium-leaching-from-the-device-mda-2019-015

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 11 March 2019