MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 BUBB DET SENSOR, LOW LEVEL II; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number	23-07-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the s3 bubb det sensor, low level ii.The incident occurred in (b)(6).A livanova representative was dispatched to the facility to investigate the issue.On site, he was able to replace the claimed malfunction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
Event or Problem Description
Livanova (b)(4) received a report that a s3 bubble detection sensor had malfunctions during procedure.There was no report of patient injury.
Event or Problem Description
See initial.
Additional Manufacturer Narrative
H.10: the cardioplegia sensor module, the bubble sensor and a sample of the used tubing were requested back to livanova deutschland for further investigation.The reported issue could be reproduced.Results revealed that it was caused by the defective bubble sensor having a vga-gain value outside specification.A review of the dhr's did not identify any deviations or nonconformities relevant to the issue.

• Brand Name: S3 BUBB DET SENSOR, LOW LEVEL II
• Common Device Name: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8398675
• Report Number: 9611109-2019-00133
• Device Sequence Number: 253098
• Product Code: DTW
• UDI-Device Identifier: 04033817900573
• UDI-Public: (01)04033817900573(11)180306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955152
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 23-07-40
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1