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 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in headington, oxford, united kingdom.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.A loaner device will be provided to the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report of multiple motor control failure error messages followed by another message ¿internal malfunction - remains operational¿.The s5 double head pump has been taken out of service.Reportedly, cardioplegia pump stopped working, after switching pump off and then on again the pump started to work again as expected.This has happened on a few occasions during priming.There was no patient involvement.

Manufacturer Narrative

H10: the device was returned and further functional tests were performed.No deviation could be found.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

Event Description

See initial report.

Manufacturer Narrative

Livanova received report of multiple motor control failure error messages followed by another message ¿internal malfunction - remains operational¿.There was no patient involvement.Investigation based on the pictures provided by the customer revealed that the motor control failure occurred on all the pumps at the same time during the procedure.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.All the pumps used during the procedure were tested without finding any deviation.Analysis of the serial read-out of the pump (real time device parameters and setting recording file) confirmed that, on event day, a motor control failure has occurred (as per provided picture).Analysis identified also software resets.The cardioplegia pump was returned to be further analyzed.The roller pump was tested for 6 hours at the maximum allowed rpm (250 rpm) with the tubing size pre-set by the customer (1/4 tubing size).No deviations were observed.No error messages were displayed on the s5 control display module.Review of the livanova complaint databased revealed that the complained cardioplegia pump was involved in a previous similar case.Investigation of the previous event suggested that the root cause of the reported event was external electromagnetic interferences (emi) in the operation theatre.Based on all the above information, the most likely root cause of this reported event is traced back to emi.The risk is in the acceptable region.No action is deemed necessary.Livanova will keep monitoring the marked.

Event Description

See intial 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15347773
• MDR Text Key: 299178228
• Report Number: 9611109-2022-00454
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)160126
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• 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: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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