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

Model Number 25-40-45

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The defective gas blender was requested to livanova (b)(4) for repair and investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If additional information pertinent to this event will be receive, they will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a s5 gas blender system mixes outside due to a defective mass flow controller.The issue has been identified during maintenance.There was no patient involvement.

Manufacturer Narrative

The involved gas blender was returned to livanova (b)(4) for investigation.Examination revealed that the gas controller was not working as expected.Through follow-up communication with the customer, livanova (b)(4) was informed that the facility was electing to not repair the device.The gas blender was returned to the customer without repair.As the customer requested the device back before an in-depth investigation could be performed, a specific root cause could not be determined.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; GM
• MDR Report Key: 7233348
• MDR Text Key: 98758412
• Report Number: 9611109-2018-00079
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1