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

Model Number 25-40-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

The gas blender system 25-40-00 is not distributed in the usa, but it is similar to gas blender system 25-40-45, which is distributed in the usa (510(k) number: k052601).This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in (b)(6).The defective gas blender system was returned to livanova (b)(4) for further investigation.During the investigation a livanova service engineer was able to confirm the reported issue und could be traced to a defective dc-supply board.Therefore the defective board was replaced to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

Livanova (b)(4) received a report that during bypass the perfusionist heard an audible alarm from the s3 gas blender system and saw the error message.There was no report of patient injury.

• Brand Name: S3 GASBLENDER 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 caesar ; 14401 w. 65th way; arvada, CO ; 2812287260
• MDR Report Key: 7337110
• MDR Text Key: 102343999
• Report Number: 9611109-2018-00218
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2005
• 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