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

Model Number	23-27-40
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s3 low level ii sensor.The incident occurred in (b)(6).(b)(4).Additional investigation of the level sensor was not possible as it was scrapped by the customer.At this time, it is unknown exactly what was "defective" on the level sensor.A replacement level sensor has been provided and no further issues have been reported.As an investigation could not be performed, a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by customer.
Event or Problem Description
Livanova (b)(4) received a report that the s3 low level ii sensor was found to be "defective" during priming.There was no patient involvement.

• Brand Name: S3 LOW LEVEL II SENSOR
• Common Device Name: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 6812030
• Report Number: 9611109-2017-00653
• Device Sequence Number: 13701083
• Product Code: DTW
• UDI-Device Identifier: 04033817900610
• UDI-Public: 010403381790061011151103
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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: 23-27-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1