HeartMate Touch alert, Unexpected pump stop.
FDA RECALL
January 2024.
The HM Touch is a tablet specifically dedicated to connect to HM2/HM3 and:
1. Display information about system performance.
2. Program system parameters.
3. Assess and track alarms.
Abbott has received notifications regarding issues with Heartmate (HM) Touch due to inappropriate stopping of the pump.
Unexpected pump stop could result in hemodynamic compromise or syncope.
The company has reported that incidents occurred when the "Stop Pump" sequence was activated and communication was disrupted before the "Stop Pump" sequence was completed.
If communication is interrupted, “Stop Pump” sequence stay in the App’s queue. When a new HM2/HM3 connects to HM Touch, communication resumes, triggering the “Stop Pump” command.
This results in the LVAD starting if it was not running, or in the LVAD stopping if running at the time of connection.
This issue has been detected in version 1.0.32 of the HM Touch app.
The company has informed customers, and recommendation is as follows:
1. Do not disconnect the HM2/HM3 system controller until "Stop Pump" sequence screen with the red progress bar is over.
2. When the process is completed, the screen automatically changes to the one presented in the figure.
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