The Food and Drug Administration (FDA) has announced a critical update for the use of Automated Impella Controllers (AIC) by Abiomed. This action relates to updated use instructions following an identified risk involving device-detection failures. Health care providers and institutions that use Impella pump systems must act accordingly to ensure patient safety during procedures.
What changed?
Abiomed has identified a detection issue in the Automated Impella Controller (AIC) that affects its ability to recognize an Impella pump when connected. The problem can arise during console-to-console transfers or the initial start of a procedure. The AIC does not issue a visible alarm on its screen to notify the user of the problem. If unaddressed, this issue could result in inadequate hemodynamic support, a critical concern for patients in cardiogenic shock who may not tolerate prolonged periods of instability.
Which devices are impacted?
The recall addresses all Automated Impella Controllers used with Abiomed Impella blood pumps. These pumps provide temporary partial or full heart support to patients needing hemodynamic stabilization or cardiac unloading to facilitate recovery. No specific product codes or serial numbers were listed in the announcement. For detailed product identification, users can refer to the unique device identifier (UDI) system integrated into this medical device.
What actions has the manufacturer taken?
On June 23, Abiomed issued a letter to inform affected customers about the problem. They recommend updates to the instructions for use and offer guidance on managing detection failures. Recommended actions include:
- Having a back-up AIC available in case of device failure.
- During console-to-console transfers: Switch back to the prior console to restore patient support if the AIC screen does not progress after 20 seconds. If an alarm appears on the prior console, use a different AIC if available.
- Restart the console displaying the error before attempting to re-initiate the transfer.
- At initial case start: Restart the case on a different console if the AIC screen remains static for over 20 seconds or restart the faulty console prior to reconnecting the Impella pump.
What are the risks?
The detection issue can lead to insufficient blood circulation for patients relying on Impella pumps, especially those in critical conditions such as cardiogenic shock. As of the latest report on June 13, Abiomed has linked three deaths to this issue, although no serious injuries have been directly reported.
How can users report problems or adverse events?
Healthcare professionals and consumers should contact Abiomed directly for concerns, questions, or quality issues at 978-646-1400. Additionally, adverse events or device quality issues can be reported through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.
Recommended next steps for users
Facilities using the Automated Impella Controllers should review the updated instructions for use, ensure availability of a back-up device, and circulate the revised guidance among clinical and technical staff. If affected products have been forwarded to another location, users must inform those facilities immediately so appropriate actions can be taken.
FDA resources and further information
The FDA has categorized this recall as its most serious type due to the potential risk of severe injury or death. Users can utilize the FDA’s device identification and recall databases to validate affected products, review labeling requirements, and access information on the benefits of the UDI system.
Conclusion
This update is a critical reminder of the importance of following the latest manufacturer instructions. The use of faulty medical devices, particularly for life-supporting technologies, can have severe consequences for patients. Abiomed and the FDA both emphasize the need for timely action and adherence to the updated guidelines to mitigate risks.
Disclaimer
This article provides information for healthcare professionals and related stakeholders. It does not constitute legal or professional advice. Users should consult relevant guidelines and professionals for specific concerns.
FDA Announcement
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/blood-pump-controller-correction-abiomed-updates-use-instructions-automated-impella-controllers