MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ARTERIAL CLAMP; 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	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the arterial clamp.The incident occurred in manhasset, new york.A livanova field service representative was dispatched to the facility to investigate the device and could reproduce the reported issue.In order to solve the issue, the affected arterial clamp was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The serial read-out of the cockpit (real time device parameters and setting recording file) was analyzed and confirmed that on the date of the event the reported error code was stored in the pump micro-controller.In addition, it was found that the issue occurred several times during the day in question, even after rebooting the unit.Moreover, a further error code (2450) associated to timeout of the arterial clamp (the clamp has no communication with system) was found to be occurred.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 arterial clamp gave an error message related to its defectiveness during procedure.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: several attempts were made to have the faulty unit available for internal investigation without success.A device service history review has been performed and identified that the issue has not re-occurred.Based on all the available information, it is likely to assume that the cause of the problem is a faulty component inside the claimed arterial clamp.

• Brand Name: ARTERIAL CLAMP
• 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: 19338994
• Report Number: 9611109-2024-00221
• Device Sequence Number: 8687139
• Product Code: DTQ
• UDI-Device Identifier: 04033817903116
• UDI-Public: (01)04033817903116(11)230726
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• 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
• Report Date (Section B): 09/26/2024

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: 60-05-35
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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