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

Model Number 25-40-45

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

This report was initially submitted on 25th of july.Due to an error code the submission was rejected.Contact telephone number: (b)(6).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 not able to confirm the reported issue.However, the customer requested a replacement of the device.The device was replaced by the technician and subsequent functional verification testing was completed without issues.The replacement unit was placed into service.The replaced gas blender was requested for return 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 pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that an s5 gas blender system did not deliver the correct oxygen concentration during a procedure.There was no report of patient injury.

Manufacturer Narrative

The affected part was returned to livanova deutschland for a detailed investigation.The investigator could not reproduce the reported issue.Since the complained issue could not be reproduced, a root cause could not be determined.

Event Description

See initial report.

• 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: 7717458
• MDR Text Key: 114936311
• Report Number: 9611109-2018-01099
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• 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: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1