MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND BUBBLE SENSOR 3/8 X 3/32; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	96-414-340
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the bubble sensor 3/8¿ x 3/32¿.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 did not work during procedure.No additional information is available.It cannot be excluded that bubble sensor did not detect air bubble.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: the customer replaced the bubble sensor with a new unit.Despite requested, the customer did not provide more information about the claimed failure.The sensor was returned to livanova and tested.Visual inspection revealed no external damage to the housing, cable, or connector.Functional testing showed no signs of malfunction.Based on findings, an hardware failure of the sensor can be ruled out as root cause of the event.A review of the complaints database confirmed that no additional issues related to the bubble sensor¿s monitoring functionality have been reported by the customer and no previous complaint on this unit has been reported.Based on available information and on results of functional tests that could not reproduce any failure, it could be not clearly determined if the sensor was over-sensing (alarm triggered even if no air bubble was present) or under-sensing (alarm not triggered if air bubble was present).Therefore, this specific case has been conservatively considered as under sensing and evaluated as reportable.
Event or Problem Description
See initial report.

• Brand Name: BUBBLE SENSOR 3/8 X 3/32
• 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: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21393398
• Report Number: 9611109-2025-00056
• Device Sequence Number: 18215806
• Product Code: DTQ
• UDI-Device Identifier: 04033817902447
• UDI-Public: (01)04033817902447
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 96-414-340
• Was Device Available for Evaluation?: Yes
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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