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

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 roller pump gave a motor control failure error message during procedure.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: a device service history review has been performed and identified that the unit was manufactured in 2009 and no other similar event has been reported, neither concerning trend has been identified.The read-out of the roller pump (real-time device parameters and setting recording file) was gathered and analyzed.No event stored on november 29th, therefore based on the information provided about event the most likely date was november 28th.The motor control failure is confirmed by two events occurred on 28th november 2023 and they represent a can interruption between hms and hkr boards and subsequent shut down of hms board and motor.In addition, there are a lot of error messages indicating internal and system can disturbances, as well as memory issue for the microprocessor and wrong rotation direction.This could be caused both by external electromagnetic interference or an worn microprocessor giving wrong signals to the pump and generating error.Based on all the above, it cannot be ruled out that the event was related to one of the following root causes: - failure of the can bus that prevented the can controller from sending/receiving expected signals for a certain period of time; - external interference from high frequency devices, since the malfunction was not reproduced by technician.

Manufacturer Narrative

H10: a livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Subsequent functional verification testing was completed without 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

See initial report.

• Brand Name: S5 ROLLER 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: 18381749
• MDR Text Key: 331178313
• Report Number: 9611109-2023-00652
• Device Sequence Number: 1
• Product Code: DWB
• 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,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2009
• 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