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

Model Number	23-07-50
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova deutschland manufactures the bubble detector.The incident occurred in japan.The bubble detector was inspected at livanova japan and no issue could be reproduced.Device responded as expected to different bubble sizes functional test were conforming and device returned to customer 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 that a poor response of a bubbled detector during maintenance.There was no patient involvement.
Additional Manufacturer Narrative
H10: complaints database analysis revealed no similar event since unit installation in 2015.As per s5 system instructions for use, the 3/8¿ bubble sensor is designed to detect micro bubble with diameter greater than 4 mm.Based on the technical intervention, a hardware malfunction can be ruled out.However, it cannot be ruled out that reported event could be traced back to lack of knowledge of the user who expected the sensor to detect bubbles smaller than 4 mm.
Event or Problem Description
See initial report.

• Brand Name: SORIN S3 BUBB 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: 16102943
• Report Number: 9611109-2023-00009
• Device Sequence Number: 20751327
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)150807
• 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
• Report Date (Section B): 12/07/2022

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: 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: 12/07/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2015
• 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