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

Model Number	48-50-00Z
Medical Device Problem Code	Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the bubble detector.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 of s5 bubble sensor issue during set up.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
D.4.The catalogue and the sn of the bubble sensor have been provided and relevant field updated.The udi field has been upadated.D.4.The sn of the bubble sensor has been provided and manufacturing field updated.H.11.According to follow up, the bubble sensor stop working during the case and a new bubble sensor has been sent to the customer to fix the issue.The perfusionist has disposed the complained bubble sensor.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
A device service history review was performed and revealed that no similar events were identified on this device, so the affected module had never been replaced since installing the s5 in 2024.Bubble sensor under-sensing malfunction can be caused by a defective bubble sensor cable; defective bubble sensor module and/or bubble sensor not properly connected to its module (user error).Based on above, the most likely root cause of the reported event is an early failure of the bubble sensor.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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: 20638953
• Report Number: 9611109-2024-00534
• Device Sequence Number: 17984413
• Product Code: DTQ
• UDI-Device Identifier: 04033817902683
• UDI-Public: (01)04033817902683(11)240801
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,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: 48-50-00Z
• Device Catalogue Number: 23-07-50
• Was Device Available for Evaluation?: No
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 01/22/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/05/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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