MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	12-80-40
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the electrical venous occluder (evo).The incident occurred in birmingham, united kingdom.Livanova field service technician was dispatched on site to investigate the device and confirmed the reported condition.Once the unit was rebooted, no error was displayed and the event did not re-occur.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 that an electrical venous occluder (evo) was found to be defective.The event occurred before the start of the procedure.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
According to investigation it cannot be excluded that the error was generated by the customer that performed the calibration with open venous clamp cover.Anyhow, the system should not give such an alarm in such a situation.Alternatively, a hw failure or an isolated/temporary issue affecting the vc occurred.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: the analysis of the serial red-out files has revealed that error code 2551 was recorded.The mentioned error means that the motor of the venous clamp is defective.The clamp performs a movability test with a timeframe of 10 minutes when the clamp is not fully closed.If the test fails the notification 2551 is sent from the control unit and it is displayed on the hlm cockpit.In addition, a pattern of actions that provokes the error has been identified, which consists of calibrating the venous clamp when the clamp cover is opened.The log analysis has confirmed the issue but is not sufficient to determine the root cause of the problem.Indeed, it cannot be stated whether the issue was due to a fault within the clamp or it occurred after the perfusionist tried to calibrate the venous clamp when the cover was opened.Per the information collected and from the analysis of the pictures received from the customer, the error message was displayed while the user was in pre-bypass mode (before entering the case) and some seconds later a message reporting that the venous clamp cover was opened was shown.Therefore, considering that: - the device was tested and no deviations were identified, - the issue occurred before the user entered the case, - the message "venous clamp cover open" was displayed, it cannot be excluded that the error code was generated following the user tried to calibrate the venous clamp and the clamp cover was open.Based on the collected elements, the root cause of the issue cannot be determined with certainty.A temporary fault of the clamp may have occurred as well as it cannot be ruled out that the error code was (wrongly) triggered by the console when the user tried to calibrate the venous clamp when the cover was open.
Event or Problem Description
See initial report.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 19938393
• Report Number: 9611109-2024-00355
• Device Sequence Number: 17995589
• Product Code: DWF
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)240129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082344
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: 12-80-40
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 09/27/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/11/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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