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 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.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).A livanova field service representative was dispatched to the facility and was able to reproduce the error after two days of testing.Therefore the device was then sent to livanova (b)(4) for further investigation.During the investigation the reported failure could not be reproduced.Subsequent functional verification testing was completed without issues.As the issue could not be reproduced or confirmed, a root cause was not identified.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

Livanova (b)(4) received a report that the s3 gas blender system displays the error message after procedure.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; lindbergstr. 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: 7326325
• MDR Text Key: 102078750
• Report Number: 9611109-2018-00191
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2000
• 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