MAUDE Adverse Event Report: LivaNova Deutschland Bubble Sensor; Console, Heart-Lung Machine, Cardiopulmonary Bypass

Model Number	3/8"
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a bubble sensor which could not detect properly bubbles.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: Bubble Sensor
• 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: 50836615
• Report Number: 9611109-2026-90441
• Device Sequence Number: 10059892
• Product Code: DTQ
• UDI-Device Identifier: 04033817900597
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 3/8"
• Device Catalogue Number: 23-07-50
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown