MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH BUBBLE SENSOR 3/16¿ X 1/16¿; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	49-00-10
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.H11: 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 received a report about bubble sensor alarm not triggered.At the removal of cross clamp and decannulating of the aortic root vent, the cardioplegia line was drained back of blood via gravity.When the air/blood interface passed through the cardioplegia bubble sensor, the alarm did not activate.The sensor was inspected, with the latch of the sensor then opened, but still, the alarm did not go off.It was not until the bubble sensor was turned off and back on, that the alarm activated and the orange audible and visual alarm was occurred.The pre-bypass checks of all sensors was completed, and the alarm performed as it should.There was not patient impact reported.
Additional Manufacturer Narrative
The low-level bubble log file was retrieved and analyzed and no technical error message related to a bubble sensor failure was stored around the time of the event.The essenz cockpit logs were pulled out and found corrupted therefore no further analysis could be performed.Complaints database analysis revealed that no further similar issue has been submitted for this unit and the reported issue can be considered as a one-off event.Statistical database analysis didn't detect any adverse trend related to the reported issue.Bubble monitoring malfunction can be caused by defective bubble sensor module or defective bubble sensor.Based on the above facts and according to the information collected and analyzed, the root cause of the reported case cannot be determined.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: BUBBLE SENSOR 3/16¿ X 1/16¿
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20019977
• Report Number: 9611109-2024-00372
• Device Sequence Number: 7476261
• Product Code: DTQ
• UDI-Device Identifier: 04033817902423
• UDI-Public: (01)04033817902423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 49-00-10
• Device Catalogue Number: 96-414-320
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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