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

Model Number 48-40-00

Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: there was no patient involvement.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device evaluated by mfr: device not returned.

Event Description

Livanova (b)(4) received report of a s5 system showing an error message due to a level detector shutdown and with pump display issues during procedure.There was no report of patient injury.

Manufacturer Narrative

The pump and the board were returned to livanova deutschland for further investigation.During the evaluation the reported issue could not be reproduced.The device worked according the specification.The visual inspection of the device identified the can connector on a board not being completely seated in its holder.As the issue could not be reproduced, a root cause was not identified.

Event Description

See initial.

Manufacturer Narrative

Through follow-up communication livanova deutschland learned that a livanova field service representative was dispatched to the facility to investigate.He checked all pumps and modules, first disconnected and then connected one by one.The device was working properly and the reported error was no longer displayed.The serial read-out of the pump has been supplied.Based on the analysis of the data provided, the investigator could establish that the main pump had no connection to the system panel at the time of the reported event.A review of the dhr could 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.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8448723
• MDR Text Key: 139740153
• Report Number: 9611109-2019-00186
• 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: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2019

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
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 05/27/2019
• Supplement Dates FDA Received: 05/16/2019; 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1