MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ARTERIAL CLAMP - AC ARM SHORT; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	60-05-30
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the arterial clamp.The incident occurred in usa.Recommended to check connections, function and circuit breaker livanova initiated an investigation.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 the arterial clamp displayed error arterial clamp defective-timeout of the arterial clamp (e2450) during set up.There is no report of any patient injury.
Additional Manufacturer Narrative
The installation has started on april 19, 2024 and completed on april 23 (except for a pressure module).The system was updated without any issues.On may 6, livanova field service was informed the cockpit would not turn on and the rest of the system was on.Biomeds were able to control pumps with the knobs on the cockpit, and no visuals were being displayed.They've traced the cables to make sure everything was plugged in properly and it still would not turn on.It was just a blank screen.The livanova field service went to the customer site and he had to start several times the cockpit to be able to turn it on and this is when the arterial clamp compatibility issue arose: 2450 defective - replace clamp.The livanova field service tried flashing cockpit and the arterial clamp would not show up in the flashnscan software.It was decided to install a new clamp.On may 7, the livanova field service went to the customer to install the new arterial clamp and the same issue of the clamp being defective was still showing up on the cockpit.On may 8, the livanova field service went again to the customer side and noticed that the software was still stuck in the boot mode and could not communicate with the essenz system and noticed a file was not loading properly and was not showing up in the flashnscan software.Solved this, fse was able to get the system out of boot mode and flash the original arterial without any problems.The livanova field service tested the unit for about two hours after that and everything was working properly.All of the alarms and defective issues have been cleared on the cockpit.No hardware deviation of the clamp has been detected.During troubleshooting on site the issue with the arterial was traced back to a software issue with the flash can tool used to upgrade the essenz software problem.The issue is always detectable before use and does not allow to use the clamp.Therefore, the event has unlikely possibility to cause any patient issue and thus the event has been reassessed as not reportable.

• Brand Name: ARTERIAL CLAMP - AC ARM SHORT
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 19465653
• Report Number: 9611109-2024-00243
• Device Sequence Number: 18016872
• Product Code: DTQ
• UDI-Device Identifier: 04033817903109
• UDI-Public: (01)04033817903109(11)240201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 60-05-30
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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