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

Model Number	23-07-50
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the bubble detector.A livanova field service representative was dispatched to the facility to investigate the device and was not able to duplicate issue.The representative changed out bubble sensor and verified the system was working properly per service manual specifications.According to customer, the bubble sensor was not alarming or adjusting flow.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 is not working during set up.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: a device service history review was performed and revealed that no similar events were identified on this device, therefore the affected bubble module had never been replaced since installing the s5 console in 2020.Based on investigation's results of previous similar complaints, bubble sensor under-sensing issue can be caused by: - a defective bubble sensor cable; - a defective bubble sensor module; - bubble sensor not properly connected to its module (user error).Based on above, the most likely root cause of the reported event is a failure of the bubble sensor.

• Brand Name: BUBBLE DETECTOR
• 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: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20756849
• Report Number: 9611109-2024-00559
• Device Sequence Number: 20938035
• Product Code: DTQ
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)201202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• 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): 02/20/2025

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: 23-07-50
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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