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

Model Number	23-07-50
Medical Device Problem Codes	Deflation Problem (1149); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a defective bubble sensor during priming.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the bubble sensor.The event occurred in germany.Bubble sensor cannot be repaired.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: through follow up communication with livanova field service representative, it was learned that the bubble sensor cushions are deflated: this failure leads to an over sensing of the sensor.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 or death.Therefore, the reported event has been re-assessed as not reportable.The unit is installed since 2020 and an analysis of the complaint database did not reveal further events related to this bubble sensor.A new bubble sensor will be shipped to the customer for the replacement.The issue is a 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.
Event or Problem Description
See initial report.

• Brand Name: BUBBLE SENSOR FOR 3/8 TUBING
• 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: 16990394
• Report Number: 9611109-2023-00231
• Device Sequence Number: 6343342
• Product Code: DTQ
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)200114
• 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

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: 23-07-50
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2020
• 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