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

Model Number 10-85-00

Device Problem Pumping Stopped (1503)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in homewood, alabama.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The motor control board and motor driver board.The problem could be solved.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 received report that a s5 system displayed an error message "no monitoring/control pump".A s5 double head pump stopped, gave an audible beeping and touchscreen was not displaying time/volume delivered.The perfusionist power cycled the pump but this did not correct the problem.Perfusionist swapped the device with a spare unit and successfully completed the case.There was no patient injury.

Manufacturer Narrative

H.10: based on service activity findings, the root cause of the reported issue can be traced back to faulty motor controller board and motor driver board.

Event Description

See initial report.

• Brand Name: S5 DOUBLE HEAD PUMP
• 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: 15299785
• MDR Text Key: 300246958
• Report Number: 9611109-2022-00432
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)180416
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• 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