The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
The US Food and Drug Administration (FDA) has issued an early alert regarding Abiomed’s Automated Impella Controller, citing purge pressure issues that could lead to serious patient harm. The issue stems from purge retainer failures, which can cause alarms, interruptions in therapy, and potential pump stops.
According to the FDA communication, Abiomed identified that cracks in the purge retainer are contributing to the failures. The company determined that the force applied by users during the insertion and removal of the purge disc is a factor in these failures. A faulty purge retainer can affect the system’s ability to regulate purge pressure and detect the purge disc, potentially leading to a complete loss of hemodynamic support for the patient.
The agency notes that a loss of hemodynamic support poses a serious risk to patient health and may result in permanent impairment or death. As of Aug 27, Abiomed has reported five serious injuries associated with this issue, with no reported deaths.
The Automated Impella Controller serves as the primary user interface for Impella Catheters, which are used to reduce the workload of the heart’s left ventricle and provide circulatory support.
Abiomed sent a letter to all affected customers on September 16 outlining recommended actions. While hospital inventory may continue to be used, the company will collect the affected controllers to perform necessary purge retainer updates. The FDA is currently reviewing information about the device issue and will provide updates as new information becomes available.
Healthcare professionals are encouraged to report any adverse reactions or quality problems experienced with these devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
ID 19681581 © Kaspri | Dreamstime.com
