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

Model Number	23-07-50
Medical Device Problem Codes	Over-Sensing (1438); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the bubble sensor.The incident occurred in usa.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 a bubble sensor malfunction-not reading anything during a procedure.There is no report of any patient injury.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Device service history review revealed that no other similar case was notified since device installation in 2017.Service confirmation was provided and reported that the bubble sensor was replaced by customer with a new one due to worn out cushions.Worn/deflated bladders of bubble sensor can result in oversensing.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.The issue is a known failure that is related to silicone oil diffusion through cushions causing false alarms, which was investigated.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 ifu to perform an operational check during priming prior to the use in the procedure and how to appropriately respond to an alarm.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Additional Manufacturer Narrative
**udi related data quality updates only** d2.Correct device product code and common device name updated in the dedicated sections d2a and d2b.D4.Correct device model number (23-07-50) updated in the dedicated section.G4.Correct pma/510(k) number updated in the dedicated section.
Event or Problem Description
See initial report.

• Brand Name: BUBBLE SENSOR DETECTOR
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18407709
• Report Number: 9611109-2023-00658
• Device Sequence Number: 15400636
• Product Code: DTQ
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)170727
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 08/02/2024
• 2 Devices were Involved in the Event: 1 2

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
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: Not provided; 08/02/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 04/19/2024; 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2017
• 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