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

Model Number	SRD S5 CONSOLE FOR 4 PUMP
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of bubble detector issues during a procedure.Customer reported that is likely a software issues.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the bubble detector.Through follow up, livanova was informed the customer has replaced the bubble sensor with a new one.Customed did not provide information about the complained sensor.According to information, customer had error massage incompatible.Therefore the software was upgraded to revision sw338 and all was working correctly.The tested sistem was likely including the new (replaced) sensor.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: according to the collected information, claimed sensor was replaced by a new one and no further issue occurred.Complaints database review revealed no other similar event reported since unit's manufacturing date.Based on investigation findings, the most likely root cause of the event was addressed to software incompatibility between the hlm and bubble detector.No concerning trend was identified for this specific failure mode.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 DETECTOR
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MUNICH; 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: 21984687
• Report Number: 9611109-2025-90106
• Device Sequence Number: 11840348
• Product Code: DTQ
• UDI-Device Identifier: 04033817902676
• UDI-Public: 010403381790267611220329
• Combination Product (Y/N): N
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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
• Device Model Number: SRD S5 CONSOLE FOR 4 PUMP
• Device Catalogue Number: 48-40-00Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2022
• 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