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

Model Number 48-40-00

Device Problem Failure to Auto Stop (2938)

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

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).A video of the fault was provided to livanova.The video shows that the user restarted the s5 system and the stop link function worked properly again.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that the stop link function did not work on a s5 system.The follower pump did not stop when the master pump stopped.There was no report of patient injury.

Manufacturer Narrative

H.10: further analysis of the video provided revealed the presence of an error message ¿no monitoring on pump¿.That means that the stop-link function was interrupted.There is not the symbol of the stop-link on the pump panel.In this condition, with stop-link function deactivated, the pump will not stop.Through follow-up communication livanova learned that the reported issue is not always reproducible.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility and a technical safety inspection was conducted with positive results.The device worked as per specifications and was returned back to service.The pump is still in use at the customer site and no further complaints regarding this specific issue have been received so far.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The machine was found to be working within specification and no deviation could be identified.Subsequent functional verification testing was completed without further issues and the unit was returned to service and the pump is in use since then.Based on the fact that no fault could be found of the device and on the fact that no further complaints regarding this issue on this machine have been reported up to date, it is reasonably to assume that the issue did not recur.The reported issue could be caused by: - master pump turned off after stop-link function activated - can connector of master pump broken - can interruption (broken wiring or emc disturbance) an hardware failure, such as broken master pump can connector as well as broken wiring, can be excluded from the possible root causes based on the fact that the issue did not recur and the machine passed all functional tests successfully and is fully functional at the customer site.Thus, based on the available information, it cannot be ruled out that emc disturbances or master pump being turned off after stop-link function activated may have led to reported issue.However, since the event was not reproducible during on-site visit and no further complaints regarding this issue /machine have been reported , the exact root cause of the event could not be determined.

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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12007729
• MDR Text Key: 256458671
• Report Number: 9611109-2021-00320
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2017
• 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