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

Model Number 25-40-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement. 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). 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 reproduced. During investigation no error code was displayed. The service engineer performed a routine maintenance and a recalibration. Subsequent functional verification testing was completed without further issues and the unit was returned to the customer. A review of the dhr could not identify any deviations or nonconformities relevant to the issue. Initially, this event was determined to be non-reportable, as the device is not distributed in the usa. However, upon further review, it has been concluded that the device is similar to one that is distributed in the usa. A retrospective review of all complaints for this type of device was performed and this event has been reevaluated as reportable based on the new decision.

Event Description

Livanova (b)(4) received a report that a s3 gas blender system displayed an error message during priming. There was no patient involvement.

• 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. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7233351
• MDR Text Key: 98758159
• Report Number: 9611109-2018-00080
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 25-40-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse