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

Model Number	96-414-320
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report about a bubble sensor defective.No patient impact reported.
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.H11: 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
H11: through follow-up communication livanova learned the device serial number which was used during the surgery.Model/serial numbers have been added to the dedicated d.4 section.Also unique identifier (udi) number have been updated accordingly.In addition, it was learned that the issue was related to an error message "bubble sensor defective" displayed on the essenz console.Based on the information received (presence of error message "bubble sensor defective"), the event has been re-assessed as not reportable.In case of bubble module/sensor failure, the user is warned through warnings/error messages on essenz cockpit and audible tone.In such situation, as per device instructions for use, the user is required to troubleshoot the problem to identify and eliminate the cause of the alarm.If this is not possible, the user is required to replace the bubble sensor/module.In the extreme situations: an air bubble may pass undetected during troubleshooting phase while warning message are displayed and the pump would not stop.The situation in which the bubble detection function is malfunctioning, and air is delivered to the patient right after the warning message is displayed is unlikely to occur.An air bubble may transit, the bubble alarm sounds, and the pump is not stopped due to link between pump and bubble detection function being interrupted.The situation in which the arterial pump is no longer monitored by the bubble detection function and air is delivered to the patient right after the warning message is displayed is unlikely to occur.However, an arterial filter must always be used as per device instruction for use to further mitigate the risk of embolism.In addition, the user is required to take extra care while completing the perfusion without the control or monitor.Thus, any failure of bubble monitoring/control function which may result in under-sensing before procedure with presence of error messages, is not likely to result in death or serious injury and the event is assessed as non-reportable malfunction.Similar issue has been complained about by other customers and the returned sensors showed internal electrical damage.The supplier of the bubble sensor detector was notified of the event to address the reported failure.Based on the above facts, the most likely root cause has been traced back to the internal electrical failure of the bubble sensor.
Event or Problem Description
See initial report.

• Brand Name: ACCESSORIES
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 20018793
• Report Number: 9611109-2024-00373
• Device Sequence Number: 8590800
• Product Code: DTQ
• UDI-Device Identifier: 04033817902423
• UDI-Public: (01)04033817902423(11)220912
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 96-414-320
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2022
• 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