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

Model Number	BUBBLE SENSOR 3/8" X 3/32"
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has provided evidence of the failure.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 alarmed and stopped the pump, correctly.However, the second time it alarmed, a few minutes after the previous alarm, it sounded but did not stop the pump.There was no patient injury.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the bubble sensor detector.The incident occurred in (b)(6), italy.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
As anticipate in the previous supplemental report, a supporting evidence was provided by the customer.In detail, an image of the electronic performance monitoring (epm) case showed that the arterial flow did not drop to 0 l/min following the bubble alarm, contrary to expected behavior.Essenz cockpit log files were provided and analyzed.Analysis did not reveal any indication of bubble sensor malfunction or timeout of the bubble monitoring function associated with the arterial pump.In the cockpit log files, all rows associated with the bubble alarms are followed by a row indicating that the arterial pump stopped no error message indicating a faulty bubble sensor is stored in the log file.A review of the complaints database did not identify any similar incidents or statistically significant trends that would suggest a systemic issue.Based on the available evidence, the reported event can be classified as an isolated occurrence resulting from a temporary failure of the bubble monitoring function, likely caused by a software glitch.The glitch appears to have originated from a transient fault in the sensor communication protocol.No persistent fault was detected during post-event testing, and the system resumed normal operation, further supporting the hypothesis of a temporary software-related anomaly.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: 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 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 22036143
• Report Number: 9611109-2025-90124
• Device Sequence Number: 8177890
• Product Code: DTQ
• UDI-Device Identifier: 04033817902447
• UDI-Public: (01)04033817902447(11)240408
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K232291
• 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,Followup
• Report Date (Section B): 09/01/2025

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 3/8" X 3/32"
• Device Catalogue Number: 96-414-340
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 08/05/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/23/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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