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

Model Number 48-30-00

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6), italy.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.All displays of the system panel were blank and after powering off/on the machine it worked.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that all display of the s5 system panel became blank and monitoring functions were deactivated from the assigned pump.Error messages were displayed on the control display module of the system panel while all the others were blank.A can-bus interruption cannot be excluded.There was no patient involvement.

Manufacturer Narrative

H10: as a result of troubleshooting performed by livanova field service technician, system boards related to internal and external communication were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Most likely root cause of the event were defective system boards.

Event Description

See initial report.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15638234
• MDR Text Key: 302589858
• Report Number: 9611109-2022-00535
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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: 48-30-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1