On Nov. 19, the U.S. Food and Drug Administration (FDA) provided an update to previous communications on evaluation of device failure associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices. The update is due to the FDA continuing to receive reports since its letter in November 2018 about these devices shutting down while running on battery power, ultimately leading to pump stop and loss of hemodynamic support.

The FDA is working with the manufacturer to figure out the root of the problem, and has issued recommendations for facilities that are currently utilizing the device, such as proper battery care and ensuring that during patient use, whenever possible, the IABP is plugged into an AC power outlet. The FDA also highly encourages voluntary reports to be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program while it continues to obtain more information with plans of alerting the public about significant changes or recommendations in the future.

Read the full update.

Keywords: ACC Advocacy, United States Food and Drug Administration, Equipment Failure, Heart-Assist Devices, Hemodynamics

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