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

Model Number 25-40-47

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to replicate the reported issue and confirmed that the error message was displayed due to the unstable flow.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that on a s5 gas blender system the flow was not stable and displayed an error message during procedure.There was no report of patient injury.

Manufacturer Narrative

Two errors have been displayed during investigation at the manufacturer site confirming a deviation between the set and the actual values.The co2 mass flow controller,co2 flow sensor and the eprom have been replaced and the issue solved.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial.

Event Description

See initial.

Manufacturer Narrative

As root cause of the issue a defective co2 monitoring sensor has been identified.In order to solve the issue, the co2 sensor has been replaced.The unit has been checked without showing further deviations.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 7973259
• MDR Text Key: 123951629
• Report Number: 9611109-2018-01294
• 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,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-47
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1