MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-45

Device Problem Gas Output Problem (1266)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The affected device was returned to the manufacturer site for investigation.The reported error code could not be reproduced during functional tests.The device was found to be working within specifications.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 report that a s5 gas blender system gave an error code associated to a discrepancy between the set and the actual gas value during a procedure.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: based on investigation findings for similar cases, the reported issue can be caused by: improper hospital gas supply (a minimum pressure of 2 bar per connection should be observed.Indeed, input pressure too low can cause a discrepancy in the target and actual values, leading to the reported issue); a missed gas blender warm-up phase (user error); defective gas blender's component.Based on product analysis, any defect of device components could be excluded.Therefore, the most likely root cause of the reported event are a missed warm-up phase / an improper hospital gas supply.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12671772
• MDR Text Key: 277644876
• Report Number: 9611109-2021-00590
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K101046
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2011
• 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