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

Model Number 10-85-00

Device Problem Decreased Pump Speed (1500)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

Livanova received report that a s5 double roller pump failed during priming.While setting up the perfusionist checked the occlusion on the small roller pump and then turned the pump rpms to 0.After finishing up with preparing for the case he noticed that the screen showed dashes and no longer read 0.00 lpm and rpm.A picture was provided.The pump was restarted multiple times and plugged it into different ports on the base of the s5.However, the issue persisted and another roller pump was used for the case.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 double roller pump.The incident occurred in (b)(6).Through follow-up communication livanova learnt that the knob od the pump did not do anything when it was turned and it initially worked until it no longer showed flow or rpms.Service engineer replace the device at the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

The unit returned to the manufacturing site confirming the reported issue.The internal inspection of the device showed that the connection between the computer board and the motor power amplifier board was loose, in particular the yellow cable was completely detached from the connector.Therefore, connection was restored.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Most likely root cause of the reported event was the signal discontinuity between the electronic components, that was caused by an isolated manufacturing deviation enhanced by device use conditions/transportation.

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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15388906
• MDR Text Key: 304610652
• Report Number: 9611109-2022-00457
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817902737
• UDI-Public: (01)04033817902737(11)220622
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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: 11/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2022
• 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