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

Model Number 25-40-46

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The gas blender was returned to livanova (b)(4) for investigation and repair. During the investigation the reported error could be confirmed. A deviation with the mass flow controller for co2 and measurement deviations have been detected. Therefore the mass flow controller and the measurement bridges were replaced to resolve the reported issue. The device was calibrated and a test run was performed. Additional subsequent functional verification testing was completed without further issues and the unit was returned to service.

Manufacturer Narrative

Patient information was not provided. 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). The device has been requested for return to livanova (b)(4) for investigation. 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) received a report that an s5 gas blender system displayed an error message during a procedure. There was no report of patient injury.

• 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: 6946545
• MDR Text Key: 254083355
• Report Number: 9611109-2017-00809
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101046
• 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,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 25-40-46
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse