MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 BUBBLE DETECTOR SENSOR 3/16''; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number	23-07-55
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.The s5 bubble detector sensor 3/16'' is not distributed in the usa, but it is similar to s5 bubble detector sensor 3/8'', which is distributed in the usa (510(k) number: k955152).Livanova (b)(4) manufactures the s5 bubble detector sensor 3/16''.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a bubble sensor 3/16'' was found to be defective during priming.No additional details were provided.There was no patient involvement.
Additional Manufacturer Narrative
H.10: no other information has been made available on this specific case and the malfunction of the bubble sensor could not be determined.A quotation to customer for a new bubble sensor has been issued and is still pending approval.The defective bubble sensor was manufactured in 2016 and no other complaints were submitted in the past.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
H.10: through follow up communication with the service engineer, it was learned that the bubble sensor may have had a broken cable.However, this could not be confirmed and this case is conservatively considered as reportable event.No trend or pattern has been identified for bubble sensor malfunction.No other information has been made available on this specific case and the exact malfunction of the bubble sensor could not be determined.
Event or Problem Description
See initial report.

• Brand Name: S5 BUBBLE DETECTOR SENSOR 3/16''
• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13599407
• Report Number: 9611109-2022-00085
• Device Sequence Number: 2571670
• Product Code: KRL
• UDI-Device Identifier: 04033817900603
• UDI-Public: (01)04033817900603(11)161026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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: 23-07-55
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/29/2022; 05/10/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/27/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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