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 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The potentially involved components, motor control board and motor end-stage board, were replaced.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 (b)(4) received a report that a s5 double head pump gave a motor control failure error message during bypass.The user tried turning off and back on the device as well as the s5 system but the issue persisted.The pump was replaced with another one and the procedure could be completed.There was no report of patient injury.

Manufacturer Narrative

The involved pump is installed since 2020 and according to the review of the complaint database no further events have been reported for this unit.The reported error message can be caused by: a defective motor controller board (hms 0409); a defective motor amplifier board (hmf 0408); a defective can communication between the hms an the hmf board.A livanova field service representative was dispatched to the customer's facility.The unit was checked on site according to maintenance procedures and no deviation was detected: the roller pump worked as expected and within specification.Thus, hardware malfunctions can be ruled out as cause of the event.Based on the above facts, it cannot be ruled out that the issue was caused by an intermittent communication between the hms and hmf 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
• MDR Report Key: 11937399
• MDR Text Key: 268102220
• Report Number: 9611109-2021-00303
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1