Maquet Medical Systems USA Flow-i Anesthesia System Recalled due to Device Field Correction which can Lead to Serious Adverse Events

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Risk Managers healthcare personnel are informed by the US FDA that Maquet Medical Systems USA Flow-i Anesthesia System is recalled because a technical alarm may be generated which can lead to serious adverse events, including death.

Background of Flow-i Anesthesia System

Flow-i Anesthesia System, by Maquet Medical Systems USA, is used for anesthesia administration and control of the entire ventilation for patients not able to breathe, as well as support of patients with limited ability to breathe.

FDA Alert on Flow-i Anesthesia System

FDA’s reason for the recall is that a technical alarm may be generated on the system when using the man/auto switch and the switch might remain in between the two positions. This can cause serious adverse events, including death.

The affected model is Flow-i C30, model number 6677300 and serial number 1170.

The distribution dates are from May 9, 2010 to December 29, 2011.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Flow-i Anesthesia System

“On February 20, 2012, the firm sent its customers an Urgent Device Field Correction notice. The firm informed their customers that their Maquet Service Representative will upgrade the software in their FLOW-i Anesthesia System to the current version and also provide them with the corresponding user manual.”

Contacting the FDA to report cases with Flow-i Anesthesia System

In case of detection of adverse events or side effects related to the use Flow-i Anesthesia System, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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