Monday, July 15, 2024

Critical Correction Issued for HeartMate LVAS Monitor

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Abbott Medical has issued a correction for the Thoratec HeartMate System Monitor due to screen issues that may cause unintentional pump stops, a serious risk that could lead to severe injury or death. The FDA has classified this recall as the most serious type, emphasizing the importance of addressing these issues without removing the devices from their current locations. The HeartMate System Monitors, used exclusively by clinicians in clinical settings such as operating rooms or clinics, may display screen issues that require immediate action. Clinicians are advised to restart the System Monitor before connecting it to a patient controller if it has been running for a long period or if screen issues are observed. To restart, clinicians should turn off the unit and then turn it back on using the On/Off switch located at the back.

This process takes approximately 10 seconds, and LVAD settings will remain unchanged if the unit is restarted while connected to the patient’s controller.Clinicians should check all cables and connections if screen display issues persist after restarting the System Monitor. If problems continue, they should use a different System Monitor. In case the “Stop Pump” button is inadvertently pressed due to display issues, the pump will momentarily stop and restart unless the button is pressed for longer than ten seconds. In such cases, pressing any button on the controller can restart the pump and resolve the “Pump Off Alarm,” as per the Instructions for Use.

HeartMate

Urgent Correction for HeartMate Monitors

On May 8, 2024, Abbott Medical sent an Urgent Medical Device Correction letter to all affected customers, detailing the necessary actions for clinicians and institutions. The letter includes instructions to restart the System Monitor to resolve display issues and advises distributing the notice within the institution and to any other institutions where the devices may have been transferred. Customers are required to complete and return the acknowledgment form attached to the letter.

The recall is due to atypical behavior of the System Monitor screen, including screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and incorrect or missing information. These screen issues can cause clinicians to inadvertently change pump settings or press the pump stop button, potentially leading to serious health consequences such as decreased blood pressure, hemodynamic compromise, stroke, irreversible brain damage, heart or organ failure, and death. Although there have been 14 reported injuries, no deaths have been reported.

The HeartMate System Monitor is part of the HeartMate Left Ventricular Assist System (LVAS). It is used in operating rooms or during clinic visits to monitor system operation closely during LVAD implantation, display information about system performance, program system parameters, assess and track alarm conditions, and record data for review and analysis. An LVAS assists the heart in pumping blood when it is unable to do so effectively, either as a temporary measure while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant is not an option.

 

Resource: U.S. Food and Drug Administration, June 28, 2024

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