FDA MedWatch - Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems by Getinge

Class I Recall - Due to a Risk of Harmful Chemical Exposure

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems by Getinge: Class I Recall - Due to a Risk of Harmful Chemical Exposure  AUDIENCE: Health Professional, Patient, Risk Manager, Anesthesiology   ISSUE: Getinge is recalling the Vaporizer Sevoflurane Maquet filling due to the potential chemical breakdown of Sevoflurane, a general surgical anesthetic, that may result in inhalation and/or skin exposure to harmful chemicals. If this occurs, this may cause serious patient harms including irritation of the respiratory tract, lung edema (swelling caused by excess fluid), and severe hypocalcemia (condition in which the blood has too little calcium). There have been eight complaints regarding this device issue. There have been no reported deaths or injuries. For more information about this recall, click on the red button "Read Recall below. BACKGROUND: The Vaporizer is a component of several Maquet anesthesia gas machines. The Flow Family of Anesthesia System administers inhalation anesthesia while controlling the entire ventilation of patients who are unable to breathe, as well as in supporting patients with a limited ability to breathe. RECOMMENDATIONS: On December 9, 2021, Getinge sent an Urgent Medical Recall Letter to affected customers informing them of the product issue and potential risks to health. Getinge asked customers to take the following actions: Examine their inventory and remove any affected products. Contact Getinge Customer Service to request a return. Share this information with all current and potential Vaporizer Sevoflurane, Maquet filling users within their hospital or facility. Getinge provided the following recommendations: If at any time, the user notices the agent in the vaporizer looks cloudy or yellowish and there is a sweet-smelling pungent odor, the user should immediately stop use of the affected vaporizer. To prevent exposure, the user should be able to successfully perform a System Check-Out (SCO) procedure which may detect the failure prior to usage. If the gas analyzer test fails, a dialog box will appear to promptly inform the user. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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