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

Model Number	48-50-00
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(4).The pump and the e/p pack was returned to livanova (b)(4) for further investigation.During the intense evaluation of both parts no device malfunction could be confirmed or reproduced.The components worked according the specification.A serial readout evaluation of the pump was performed but no device malfunction could be detected.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced or confirmed, a root cause was not identified.
Event or Problem Description
Livanova (b)(4) received a report that several values which were displayed on the s5 system suddenly disappeared during procedure.There was no report of patient injury.

• Brand Name: S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 8585964
• Report Number: 9611109-2019-00319
• Device Sequence Number: 11221584
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: (01)04033817900900(11)181127
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 48-50-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1