MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND C5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 58-00-00

Device Problem Pumping Problem (3016)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the c5 system.The incident occurred in hamburg, germany.Pump serial read out analysis has been performed.Results revealed an error message stored in the micro-controller associated to hall sensor index signal faulty and the involved component are hall sensor at pump head and motor control board.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Upon internal components inspection, traces of oxidation were found on motor control board.The motor control board and the processor board were replaced and a new seal was installed on the pump head.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report of pump monitoring being faulty on a c5 heart lung machine.The issue occurred during priming.There is no known patient involvement.

Manufacturer Narrative

H.10: the root cause of the reported issue can be traced back to faulty motor control and processor boards.Most likely the presence of oxidation was caused by fluid ingress into the pump which led to the failure of electronics components on the board.

Event Description

See initial report.

• Brand Name: C5 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: 15198725
• MDR Text Key: 298046036
• Report Number: 9611109-2022-00409
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093882
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58-00-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2009
• 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