MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 DOUBLE ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problem Pumping Problem (3016)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that the flow rate knob of the s5 double roller pump was stuck during a maintenance.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 system.The incident occurred in japan.During maintenance and inspection, it was confirmed that the setting knob of pump "b" was stuck.The pump was sent to livanova japan for investigation and the issue was confirmed.The shaft angle encoder, s5 knob and related necessary parts 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

See intial report.

Manufacturer Narrative

Review of livanova complaints database revealed no similar event since unit installation in 2016.Based on available information, since the event is isolated, it cannot be excluded that the knob was blocked due to a mechanical defect which also led to the inefficiency of the shaft angle encoder.This did not allow the speed regulation of the roller pump involved.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16783509
• MDR Text Key: 314165415
• Report Number: 9611109-2023-00187
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)160809
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K210130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1