MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SORIN S3 BUBBLE DETECTOR; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number	SENSOR 1/4"
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of poor response of a bubble detector during operation check before use.The detector was replaced with another 1/4 sensor and the new sensore behaved as expected.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova deutschland manufactures the sorin s3 bubble detector.The incident occurred in japan.Follow up with the customer did not provide any further information.The bubble sensor 1/4 was received at livanova japan.Initial operation check found it working properly.Additional investigation is still on-going on the device.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: the involved bubble sensor detector 1/4, received at livanova japan, was tested extensively using tap water and physiological saline without reproducing the reported issue.The device was found to work properly.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: based on results of extensive tests done on the involved unit by livanova techincian, device malfunction can be excluded and event occurred could be related to user perception in evaluating air bubble size that should be detected by sensor.
Event or Problem Description
See initial report.

• Brand Name: SORIN S3 BUBBLE DETECTOR
• Common Device Name: MONITOR AND/OR CONTROL, LEVEL SENSING, 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: 16202469
• Report Number: 9611109-2023-00027
• Device Sequence Number: 17181684
• Product Code: KRL
• UDI-Device Identifier: 04033817900573
• UDI-Public: (01)04033817900573(11)220419
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955152
• 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): 12/20/2022

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 1/4"
• Device Catalogue Number: 23-07-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 03/31/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/08/2023; 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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