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

Model Number	10-90-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report about a master pump s/n: (b)(6) which suddenly stopped on (b)(6) 2024, between 4.00 pm and 5.00 pm.The system does not give any error messages.There is no report of patient impact.
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.H11: livanova deutschland manufactures the essenz hlm.Readout files were provided to livanova and under investigation.Through follow-up communication customer said that he did not receive any type of alarm, while they were in the cardioplegia phase they noticed that the master roller had stopped (perhaps an incorrect command on the red knob), they say that this event happened on 10/29/2024 at approximately 4:30 pm.As soon as they noticed, after a few minutes, they simply activated the master knob and it restarted without any problem.Customer did a functional check without finding any anomalies.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Per the information reported from the customer, the issue occurred around 16:30 pm.Essenz cockpit log files (real time device parameters and setting recording) were analyzed: around 16:24:08-16:24:39, several messages related to level regulation (alarm triggered and cleared several times around a few seconds) were recorded.At 16:28:21 a high-pressure alarm was recorded but at the same time cleared.It is reasonable to assume that the pump did not stop for more than a couple of seconds.At 16:30:37 a bubble alarm was recorded.At the same time, the arterial pump was stopped (a few seconds before the alarm was cleared).At 16:45 the case was started.Also, serial port was investigated: the heart -lung machine time was one hour (58 mins and 30 seconds) ahead of the essenz patient monitor (epm) time.In correspondence to events of level regulation, the arterial pump never stopped.In correspondence of event recorded at hlm time 16:28:21, none of the sampling around that time (every 10 seconds) shown a pump flow or rpm = 0.In correspondence of event recorded at hlm time 16:30:37, none of the sampling around that time (every 10 seconds) shown a pump flow or rpm = 0.The cockpit logs and the epm serial port analysis revealed no error related to an arterial pump stop.The serial port file revealed that the arterial pump did not stop for more than a few seconds during level regulation/stop events, high pressure event and bubble alarm event that occurred between 16:24 and 16:31, hlm time.In addition, it revealed that the arterial pump was not turning for more than a few seconds three times, just right before entering the bypass and in the first stages of the bypass.It is unreasonable to assume that the claimed event occurred for 20 seconds right before entering the bypass.It is unreasonable to assume that the claimed event occurred between [17:15:33; 17:16:04] as it was reported that the pump remained stopped for a few minutes whereas here the pump remained stopped for less than 1 minute.In addition, it was reported that the problem occurred between 4 pm and 5 pm.The claimed event may have occurred between 17:30:03; 17:31:54 but the cockpit log recorded no errors that may have caused the arterial pump to stop.Therefore, it cannot be excluded that the arterial pump was manually (and accidentally) stopped by the user.As a conclusion, the analysis of the log revealed no error that may explain the claimed situation.A review of the service history of the device has been conducted, indicating that no other similar events have been reported.Based on the collected information, the claimed problem can be neither reproduced nor confirmed.Therefore, the root cause of the issue remains uncertain.It cannot be excluded that the user zeroed the pump rpm by accidentally turning the knob to zero.
Event or Problem Description
See initial report.

• Brand Name: ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20797016
• Report Number: 9611109-2024-00569
• Device Sequence Number: 17875808
• Product Code: DTQ
• UDI-Device Identifier: 04033817902997
• UDI-Public: (01)04033817902997(11)240624
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10-90-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown