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

Model Number	25-40-45
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 gas blender system.The incident occurred in porto, portugal.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem 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 value.There was no patient injury.
Additional Manufacturer Narrative
H10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue on co2 channel.In addition, an error code associated to discrepancy between the actual and set gas flow value on o2 and air channels were displayed.In order to fix the issue, the microbridge mass flow sensor and controllers for co2 and o2 were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Most likley root cause of the reported event was due to defective microbridge mass flow sensor and controllers.As a consequence, sensors drift could have led to inaccurate (air/o2/co2) flow measurement readings.
Event or Problem Description
See initial report.

• Brand Name: S5 GAS BLENDER SYSTEM
• Common Device Name: GAS CONTROL UNIT, 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: 15606073
• Report Number: 9611109-2022-00516
• Device Sequence Number: 2236461
• Product Code: DTX
• UDI-Device Identifier: 04033817900702
• UDI-Public: (01)04033817900702(11)211229
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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