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

Model Number	25-40-46
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The device was returned to livanova (b)(6) where the issue was confirmed.The unit has been returned to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that an s5 gas blender system had no oxygen flow.There was no patient involvement.
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system.The event occurred in (b)(6).The device was sent to livanova (b)(4) for investigation.The service engineer inspected the device and was able to confirm the reported issue.During inspection the calibration showed a deviation in the o2 flow which was caused by a defective mass flow controller.After the replacement of the defective part, the device was re-calibrated and subsequent tests were performed successfully.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

• Brand Name: S5 GAS BLENDER SYSTEM
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 6956622
• Report Number: 9611109-2017-00823
• Device Sequence Number: 1111672
• Product Code: DTX
• UDI-Device Identifier: 04033817900702
• UDI-Public: 010403381790070211161125
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: 25-40-46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1