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

Model Number	BUBBLE SENSOR FOR 3/8 TUBING
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the bubble sensor detector.The incident occurred in (b)(6) germany.In order to solve the issue a new replacement bubble sensor will be shipped to the customer.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 a bubble sensor detector was defective during priming.No additional information is available.It cannot be excluded that bubble sensor did not detect air bubble.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: affected device was replaced with a new one and no further issue occurred.Complaints database review revealed no other similar event since unit's manufacturing date.As per available information, a specific root cause could not be determined.Possible scenarios are: bubble sensor not recognized by the hlm, bubble sensor switching size on its own, deflated bubble sensor cushions triggering false alarm, bubble sensor not detecting air.No concerning trend was identified for the above mentioned potential failure modes.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: BUBBLE SENSOR DETECTOR
• 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: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22140837
• Report Number: 9611109-2025-90164
• Device Sequence Number: 7123005
• Product Code: DTQ
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)200409
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/26/2025

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: BUBBLE SENSOR FOR 3/8 TUBING
• Device Catalogue Number: 23-07-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2020
• 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