MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	RP150
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: through follow-up communication, livanova learned that the user did not try to change the pump nor to restart the console, and decided to perform hand-crank for almost 80 minutes.Moreover, customer reported that the venous clamp and the electronic gas blender used during the procedure intermittently disappeared from the essenz cockpit display.Livanova tssi representative inspected the involved pump.The roller pump was connected to a specific port of the ep pack console and was found to intermittently appearing on the cockpit, and after a while it completely disconnected.A different pump was connected to the same port for comparison and found to be working properly.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report of a roller pump assembled onto essenz heart-lung machine (hlm) which suddenly stopped during procedure, followed by multiple alarms.Customer performed hand-crack and concluded the case without any further issue.After the end of the procedure, the unit was manually checked and the arterial pump was found properly functioning.There was no patient injury.

• Brand Name: ESSENZ ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24142362
• Report Number: 9611109-2026-90020
• Device Sequence Number: 8887692
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RP150
• Device Catalogue Number: 10-90-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 04/21/2026; 08/31/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 05/20/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown