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

Model Number	60-05-35
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the arterial clamp- ac arm long (620 mm).Preliminary investigation found: the logs were checked from october 29: the arterial clamp gave an error code 1200 (ac defective) at 7:09, the case was exited and a new case was entered.The error code 1200 was displayed once again + error code 2450 (meaning the ac clamp has communication issues with the console), the case was exited and a new case was entered.No issues recorded this time.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 has received a report of a defective arterial clamp during priming after package is open.There was no patient involvement.During the investigation of the serial read out (real time device parameters and setting recording file), it was identified the error 1200 displayed twice and error 2450 displayed once before bypass during the first stages of a procedure.Both error codes are related to a problem with the ac and might reoccur.
Additional Manufacturer Narrative
The livanova service representative assigned to the case replaced the clamp and removed it from service.It is unclear whether the clamp was tested before its removal, and no response was provided to the request to make the clamp available for further investigation.A review of the service history of the device has been conducted, indicating that no other similar events have been reported.A wider review of complaints was conducted, revealing that other occurrences of the issue have been reported to livanova.Based on all the available and collected information, it cannot be excluded that a failure of the arterial clamp is the cause of the issue.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 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: 20830137
• Report Number: 9611109-2024-00582
• Device Sequence Number: 14461144
• Product Code: DTQ
• UDI-Device Identifier: 04033817903116
• UDI-Public: (01)04033817903116(11)230913
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K221373
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-05-35
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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