MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S3 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-00

Device Problem Gas Output Problem (1266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Serial number is under confirmation.This information will be provided in a supplemental report if made available.As the serial number is under confirmation, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.He replaced the connecting cable to solve the problem.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 a s3 gas blender system displayed an error code during procedure.The user swapped it with another device and the case could be completed with no further issues.There was no report of patient injury.

Manufacturer Narrative

H.10: the unit was requested for further investigation.No errors occurred during the investigation test and no deviations could be detected.The unit worked as expected and within specification.Since the error occurred with more than one unit at the customer's site and it could not be reproduced during the investigation tests at livanova, it is reasonable to think that the issue is not device-related.Most likely, the issue was due to the hospital gas supply.

Event Description

See initial report.

• Brand Name: S3 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9400287
• MDR Text Key: 194160301
• Report Number: 9611109-2019-00930
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1