MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 LEVEL SENSOR MODULE; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number	23-40-20
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova manufactures the s5 sensor module level.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The module was returned to livanova (b)(4) for investigation.During the evaluation, the reported issue was reproduced.The level module did not show the state of the level in the main control display.Trouble shooting identified the cause of the issue to be corrupted data in the memory banks of the micro-controller on the board of the module.The nvmem module was flashed and a 3 day test run was conducted with the simulator switching between low and high levels every 5 seconds.No deviations occurred during this test run.The module was scrapped for safety reasons upon completion of the investigation and the customer has been provided a replacement.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that the s5 level sensor module did not display anything during priming.There was no patient involvement.

• Brand Name: S5 LEVEL SENSOR MODULE
• 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: 6803564
• Report Number: 9611109-2017-00645
• Device Sequence Number: 16433438
• Product Code: DTW
• UDI-Device Identifier: 04033817900658
• UDI-Public: 010403381790065811150915
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071318
• 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): 08/18/2017

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: 23-40-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1