MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND BUBBLE SENSOR DETECTOR; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number	23-07-50
Medical Device Problem Codes	Over-Sensing (1438); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the bubble sensor detector.The incident occurred in dortmund, germany.The sensor was replaced by a livanova field service representative.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 a bubble sensor detector could not be activated reliably, sometimes not at all.The issue occurred during maintenance activity.It cannot be excluded that bubble sensor did not detect air bubble.There was no patient involvement.
Additional Manufacturer Narrative
The unit was installed since 2022 and the analysis of the complaints database did not reveal further events related to this bubble sensor.Livanova field service technician replaced the sensor with a new one.From follow up with technician, it emerged that the reason for changing the bubble sensor was that the gel pillows were flat.The issue is a known failure that is related to silicone oil diffusion through cushions causing false alarms and is caused by a design problem.The risk of failure has been determined as acceptable.There is no information that can be provided to decrease risk beyond what is currently in the ifu to perform an operational check during priming prior to the use in the procedure and how to appropriately respond to an alarm.Event has been reassessed as not reportable since in case of bubble sensor triggering false bubble alarms, the pump is stopped by the bubble alarm even if no air is present in the monitored line.In such situations, the alarm can always be cleared/overridden by user, once the line is verified to be free of air, and the perfusion can be easily restarted.Thus, it is unlikely that a false bubble alarm will result in serious injury.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: BUBBLE SENSOR DETECTOR
• Common Device Name: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 17912433
• Report Number: 9611109-2023-00517
• Device Sequence Number: 20684091
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)220323
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K955152
• 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): 04/23/2024

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: 23-07-50
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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