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 08/01/2023

Event Type  malfunction  

Event Description

Livanova received report that a s5 gas blender system gave an error code associated to a discrepancy between the actual and set gas flow values during procedure.The unit has been turned off and on without improvement, therefore the customer switched to a manual gas blender to continue the procedure.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

The unit has been requested to the manufacturer for further investigation and repair but it is not yet shipped.The involved gas blender was manufactured in 2023 and according to the analysis of the complaints database, no further events related to this unit have been reported in the past.Based on the investigation performed for similar cases, this kind of malfunction can be caused by: improper hospital gas supply (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 (gas mass flow controllers and relative flow sensor).The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

Manufacturer Narrative

No short-term or long-term trend has been detected for the reported type of failure.The unit has been requested to the manufacturer for further investigation and repair.The issue has been confirmed and solved by replacing the mass flow controller.Based on the above findings, the first two possible root causes can be ruled out.The root cause of the event is a defective mass flow controller.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• 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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17649176
• MDR Text Key: 322259418
• Report Number: 9611109-2023-00409
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)230309
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2023
• 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