MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM; 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	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report that during a procedure a s5 gas blender system alarmed and after some seconds the gas flow stopped.The perfusionist changed to mechanical gas blender to continue the procedure.After the procedure, the perfusionist tried to start again the device and it could not be turned on.There was no patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 gas blender system.The incident occurred in bogotà, colombia.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H.10: the involved unit was manufactured in 2019 and according to the analysis of the complaints database no events related to this unit have been reported in the past.The unit was returned back to the manufacturer site and checked.The reported issue related to a missed power up of the unit after the procedure was not confirmed.However, during the intensive tests performed at the manufacturer site, the error codes related to discrepancy between actual and set co2 values were identified confirming the event.Troubleshooting revealed that the root cause of the reported alarm, which led to a subsequent gas flow stop, was a defective co2 flow sensor.The co2 flow sensor was replaced to solve the reported issue.The front panel of the gas blender, where the processor board is located, will be replaced as well.Indeed, the processor board is the component potentially involved in the issue related to the missed power up of the device reported by the customer.Since the new front panel is not equipped with the eprom, a new eprom was mounted.
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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15275720
• Report Number: 9611109-2022-00421
• Device Sequence Number: 15204139
• Product Code: DTX
• UDI-Device Identifier: 04033817900719
• UDI-Public: (01)04033817900719(11)190506
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/23/2022

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: 25-40-47
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2019
• 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