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

Model Number	SENSOR 3/8"
Medical Device Problem Codes	False Alarm (1013); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the bubble sensor.The incident occurred in (b)(6) japan.Defective bubble detector was replaced by the hospital biomedical engineer with one of the same size available and it worked without any problems.The affected unit cannot be repaired and therefore a new sensor detector will be shipped to the customer.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 detector had a poor reaction during priming.There was no patient involvement.
Additional Manufacturer Narrative
H11: through follow-up communication livanova learned that the issue was related to a false air bubble alarm, since no bubbles existed.The issue occurred after machine preparation was completed.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 and for this reason the event has been re-assessed as not reportable.A device service history review has been performed and identified that the unit was manufactured in 2016 and no other similar event has been reported.Taking into account the failure mode and the manufacturing date of the sensor (2016), it is reasonable to assume that the cushions were deflated and therefore the sensor was detecting air because the cushions were not properly adhering to the tube.The issue is a known failure that is related to silicone oil diffusion through cushions causing false alarms.Investigation revealed that the oil diffusion through cushions is a design problem.The risk of failure has been determined as acceptable.There is no information that can be provided to decrease risk beyond what is currently in the device instructions for use to perform an operational check during priming prior to the use in the procedure and how to appropriately respond to an alarm.

• 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: 20620158
• Report Number: 9611109-2024-00527
• Device Sequence Number: 7534740
• Product Code: DTQ
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)161017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/20/2025

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: SENSOR 3/8"
• Device Catalogue Number: 23-07-50
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2016
• 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