MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH BUBBLE SENSOR FOR 3/8 TUBING; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	23-07-50
Medical Device Problem Codes	Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the bubble sensor.The incident occurred in japan.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 has received a report that, during priming, the bubble sensor was not correctly working.It was installed several time even adding gel and it did not improve.The device was replaced.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: through follow-up communication livanova learned that the correct serial number of the bubble sensor detector involved is (b)(6).Model and serial number have been updated in the dedicated d.4 section.Furthermore, the affected part was returned to livanova deutschland for a detailed investigation: it was confirmed and reproduced that the bubble sensor gave false alarms, over-reacting even if no air bubbles were present.Based on this information received, the event has been re-assessed as not reportable.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 patient serious injury or death.Upon inspection it was also found that the bubble sensor cable was partially disconnected and the cushions were not deflated.New bubble sensor will be sent to customer as troubleshooting.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar event has been reported.Taking into account the outcome of the service activity, it cannot be ruled out that the most likely root cause of the reported issue was related to the partial disconnection of the cable.

• Brand Name: BUBBLE SENSOR FOR 3/8 TUBING
• 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: 17359140
• Report Number: 9611109-2023-00340
• Device Sequence Number: 12432492
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)180821
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023
• 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
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2018
• 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