MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ELECTRONIC GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	25-40-47
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report that the electronic gas blender is contantly alarming and air flow is not steady during maintenance.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 gas blender system.The incident occurred in united states.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The affected part was returned to livanova deutschland for a detailed investigation.The technician could not reproduce the reported issue.However, another error code associated to a discrepancy between the actual and set gas flow values was displayed for co2 channel.As per technical inspection mass flow controller for co2 and flow sensor were identified as failed components and need to be replaced.The affected unit was manufactured in 2021 and according to the review of the complaints database no further complaints 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 (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 (gas mass flow controllers and relative flow sensor).Based on the technical intervention, the root cause of the reported issue has been traced back to defective gas blender's component (gas mass flow controllers and relative flow sensor).
Event or Problem Description
See initial report.

• Brand Name: ELECTRONIC GAS BLENDER
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 17160879
• Report Number: 9611109-2023-00272
• Device Sequence Number: 5757968
• Product Code: DTX
• UDI-Device Identifier: 04033817900719
• UDI-Public: (01)04033817900719(11)210714
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 25-40-47
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown