MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONSOLE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	48-40-00
Medical Device Problem Codes	False Alarm (1013); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the bubble detector.The incident occurred in (b)(6).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 that a bubble sensor detector was defective.No additional information is available.It cannot be excluded that bubble sensor did not detect air bubble.The issue occurred at setup.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: through follow-up communication with livanova field service representative in charge, it was learned that the bubble sensor membranes were too deflated creating air bubbles false alarm.In case of bubble sensor triggering false bubble alarms, the pump is stopped by the bubble alarm even if no air is present in the monitored line.In such situations, the alarm can always be cleared/overridden by user, once the line is verified to be free of air, and the perfusion can be easily restarted.Thus, it is unlikely that a false bubble alarm will result in serious injury.For this reason, the event has been re-assessed as not reportable.

• Brand Name: S5 CONSOLE
• 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: 20618783
• Report Number: 9611109-2024-00521
• Device Sequence Number: 15658758
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: (01)04033817900887(11)180831
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 48-40-00
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2018
• 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