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

Model Number 25-40-00

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The s3 gas blender 25-40-00 is not distributed in the usa, but it is similar to s5 gas blender system 25-40-45, which is distributed in the usa (510(k) number: k101046).Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to reproduce the reported issue.The device has been requested for return to livanova (b)(4) for further evaluation.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) receive a report that an s3 gas blender system displayed an error message and the flow stopped during a procedure.The user rebooted the device to reestablish flow.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in (b)(6).The device was returned to livanova (b)(4) for further investigation.The problem could not be confirmed.The service engineer performed a routine maintenance.Afterwards, a test run and a tsi check were performed successfully and the device was returned to the customer.

• Brand Name: S3 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. 65thway; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6953496
• MDR Text Key: 90413925
• Report Number: 9611109-2017-00818
• 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,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2004
• 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