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

Model Number 25-40-45

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

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). Livanova (b)(4) received a report that after turning on the s5 gas blender system it displayed an electrical error e19 and an alarm sounded. They turned off the power once and rebooted, but the electrical error e19 was displayed again. The issue was noted during priming. There was no patient or user injury as a result of this event. The device was returned to livanova (b)(4) for investigation and the described error could be reproduced. The investigator found that the 73-300-141/g measurement bridge awm 5102vn and the 73-300-252 mass flow controller sor-002g o2 required replacement. The parts were replaced and the unit was reassembled and tested. Preventative maintenance, a test run, calibration and a technical safety inspection were performed without issue and the device was returned to the customer. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Livanova (b)(4) will continue to monitor the market for trends related to this type of issue.

Manufacturer Narrative

There was no patient involvement. 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 customer plans to return to device to livanova (b)(4) for investigation. 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, during setup, the s5 gas blender system sounded an alarm after 1 to 2 minutes of power and a numerical error code was displayed. The device was restarted and the error appeared again after 2 to 3 minutes. There was no patient involvement.

• 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,
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6580065
• MDR Text Key: 254222489
• Report Number: 9611109-2017-00411
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/07/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 25-40-45
• 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: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse