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

Model Number 48-40-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The date of patient death was not provided.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).Through follow up communication with the customer livanova (b)(4) learned that the patient died after the procedure while in intensive care.It was reported that no malfunction occurred during the surgery and that the device was used during later surgeries without issues.In addition, a livanova field service representative was dispatched to the facility to investigate.The service representative was not able to identify any malfunction or issue with the device.The system worked according the specification.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As no malfunction has been reported and evaluation of the device did not reveal and issues with the system, it is unknown at this time whether the s5 system contributed to the patient death in any way.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) was contacted by an attorney and was notified that a patient who underwent surgery on (b)(6) 2018 had died.It was reported that a s5 system was used during the procedure.No device malfunction was reported.

Manufacturer Narrative

A serial readout was returned to livanova (b)(4) for further investigation.A review of the readout did not identify any device failures.The device worked according the specification.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7543252
• MDR Text Key: 109218180
• Report Number: 9611109-2018-00987
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death