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

Model Number	25-40-47
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
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 colombia.The same issue has already previously occurred at the same device.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland has received a report that during ecc, the electronic gas blender constantly displayed alarm which it couldnt be silenced and some seconds next, the gas flow stopped suddendly.The perfusionist elected to change to a mechanical gas blender to complete the ecc.After the procedure the perfusionist tried to start again the egb and this could not turn on.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: the affected part was returned to livanova deutschland for a detailed investigation.The technician could confirm the reported issue.In order to fix it, eprom (erasable programmable read-only memory) memory was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on the technical service activity, the root cause of the reported event is a defective memory.

• 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: 16750550
• Report Number: 9611109-2023-00173
• Device Sequence Number: 8626914
• 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: 1
• 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): 03/20/2023

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: 03/20/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 09/04/2023
• 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