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

Model Number 25-40-45

Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The device has been returned to livanova deutschland for investigation.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 the s5 gas blender system displayed multiple error messages during multiple procedures, and the unit delivered less than the required amount of air.There was no report of patient injury.

Manufacturer Narrative

The device was returned to livanova (b)(4) for further investigation.During the evaluation the reported problem could not be reproduced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6902247
• MDR Text Key: 89382843
• Report Number: 9611109-2017-00762
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 11/26/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1