Product defect correction: Getinge Sevoflurane Quik-Fil Vaporizer, yellow substance in vaporizer

ANZCA has become aware of a product defect correction for Getinge Sevoflurane Quik-Fil Vaporizer for Flow Family Anaesthesia system, model 6886611. Eight reports have described the presence of a yellow substance in the vaporizer. In one of these instances, the presence of hydrogen fluoride was confirmed via chemical analysis.

Potential harms from inhalation of hydrogen fluoride may include irritation of respiratory tract, and in the worst case, lung oedema and/or severe hypocalcaemia up to 24-48 hours after exposure.

All reports to date occurred when using Sevoflurane Piramal or Baxter Sevoflurane. No reports have been received for Abbvie Sevorane/Ultane.

The manufacturer’s investigation has not yet determined the cause of these incidents. The manufacturer’s interim advice is:

• If at any time, the agent in the vaporizer looks cloudy or yellowish and there is a sweet-smelling pungent odor, immediately stop use of the affected vaporizer.
• To prevent exposure, the user should perform a System Check-Out (SCO) procedure before use, which may detect the failure in advance. If the gas analyzer test fails, a dialog box will appear to promptly inform the user.
• Immediately remove from use devices of this model that have been used with any other filing than AbbVie Sevorane, and quarantine to prevent further use.
• Follow further instructions in the manufacturer’s letter to affected customers.

More information is available from the Therapeutic Goods Administration (TGA) recall listing, and the United States Food and Drug Administration (FDA) medical device recall.

Update 30 June 2022: Medsafe and Getinge have advised that no affected devices have been sold in New Zealand.