MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CARDIOPLEGIA SENSOR MODULE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	27-80-20
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 cardioplegia sensor module.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).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.
Event or Problem Description
Livanova (b)(4) received a report that the s5 cardioplegia sensor module displayed "lo" and could not be calibrated during setup.There was no patient involvement.
Additional Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue.Extensive troubleshooting revealed a faulty sensor module to be the root cause for the reported issue.The module was replaced and subsequent functional verification testing was completed without further issues.The unit was returned to service.
Event or Problem Description
See initial report.

• Brand Name: S5 CARDIOPLEGIA SENSOR MODULE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 6896061
• Report Number: 9611109-2017-00758
• Device Sequence Number: 10920873
• Product Code: DTW
• UDI-Device Identifier: 04033817900740
• UDI-Public: 010403381790074011160413
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 07/23/2018

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: 27-80-20
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1