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

Model Number	25-40-46
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
Event or Problem Description
Livanova (b)(4) received a report that a s5 gas blender system displayed an error message during procedure.Due to this failure a reduced brain saturation was caused which was recovered by using the mechanical backup gas blender.There was no report of patient injury.
Event or Problem Description
See initial.
Additional Manufacturer Narrative
Through follow-up communication, livanova deutschland learned that the reported brain saturation reduction had no consequences to the patient.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The affected parts were returned to livanova deutschland for a detailed investigation.The investigator could reproduce the reported issue.The problem could be traced to defective mass flow controller and a measurement bridge.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Event or Problem Description
See initial.
Additional Manufacturer Narrative
The defective device was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be reproduced.The failure was traced to a defective measurement bridge and a mass flow controller.

• Brand Name: S5 GAS BLENDER SYSTEM
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 7876242
• Report Number: 9611109-2018-01224
• Device Sequence Number: 2076903
• Product Code: DTX
• UDI-Device Identifier: 04033817900702
• UDI-Public: 010403381790070211180530
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 25-40-46
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 02/28/2019; 04/03/2019
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 02/28/2019; 03/28/2019; 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR