MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH BUBBLE SENSOR FOR 3/16 TUBES; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	23-07-55
Medical Device Problem Code	Low Readings (2460)
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
There was no patient involvement.H10: livanova deutschland manufactures the bubble sensor.The incident occurred in germany.According to follow up with the customer, the sensor was making false alarms the day before.The analysis of the video provided confirms the low reading issue.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 maintenance, the 3/16 bubble detector did not alarm.When the sensor was opened, the alarm was triggered.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2020.It cannot be ruled out that the root cause of the event was wearing/aging of the sensor's electronics.Moreover, the technology incorporated in the sensors is very delicate and may be damaged by impact, humidity or thermal stresses.Damage does not necessarily result in total failure of the sensor, but may falsify the measured results.For this reason, all sensors should be handled with great care.

• Brand Name: BUBBLE SENSOR FOR 3/16 TUBES
• 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: 17359138
• Report Number: 9611109-2023-00339
• Device Sequence Number: 6912905
• Product Code: DTQ
• UDI-Device Identifier: 04033817900603
• UDI-Public: (01)04033817900603(11)200525
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093882
• 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

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: 23-07-55
• 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: 08/04/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2020
• 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