Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
This recall is currently active, issued November 27, 2024. It was issued by Livanova Deutschland Gmbh Lindberghstr. 25 Munich Germany.
- Recall Initiated
- October 18, 2024
- Posted
- November 27, 2024
- Recall Number
- Z-0571-2025
- Quantity
- 38
- Official Source
- View on FDA website ↗
Reason for Recall
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
Distribution
US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
Lot / Code Info
UDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436, 49PK00108, 49PK00374, 49PK00479, 49PK00480, 49PK00481, 49PK00093, 49PK00091, 49PK00092, 49PK00163, 49PK00497, 49PK00498, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00292, 49PK00291, 49PK00293, 49PK00490, 49PK00487, 49PK00488, 49PK00278, 49PK00274, 49PK00277, 49PK00275, 49PK00276, 49PK00273, 49PK00457, 49PK00458, 49PK00459, 49PK00455, 49PK00456, 49PK00290, 49PK00288
Root Cause
Software change control
Action Taken
On 10/18/24, a correction notice was emailed to customers: 1. Continue using the Heart-Lung Machine with SW HLM.1.5 as intended. 2. In the event of any cockpit reset during a procedure, use the backup control panel to make any setting adjustments as described in HLM IFU section 3.3.2 "Backup control panel." A. When prompted, press the "LAST CASE" button to retrieve the previous settings as described in HLM IFU chapter "7.1.3 Returning to the last case." If the gas blender settings were manually changed prior to the reset, adjust the settings as needed. B. If after selecting the "LAST CASE" button a second reset occurs, the "LAST CASE" button may not be available. Throughout the resetting of the system, the HLM's essential functions, including the pumps, alarms, sensors, and safety features, continue to operate as intended. After the second reset, the Gas Blender may go to Standby. If this occurs, the operator should reactivate the Gas Blender from the user interface on the Gas Blender unit to maintain operation of the Gas Blender for the procedure. After the second reset, a new case should be started from the home screen; while the machine distributes the profile again, the sensors are momentarily deactivated until the user selects the start case button. The user can skip the safety checks since they have already been performed before the reset and enter bypass mode. After starting the case, the user should update the case settings as needed. The start Case function is described in HLM IFU chapter "7.1.1 Starting a case" 3. Complete/return the response form to LivaNova.FSCA@livanova.com 4. Communicate the Correction to all personnel within your organization and any organization where affected devices have been transferred. Firm to contact customers to schedule a software update, available no later than 10/31/24. For questions regarding the correction, contact the firm at: LivaNova.FSCA@livanova.com.