MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 SYSTEM AND GAS BLENDER AND C5 SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-45

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement. Livanova (b)(4) manufactures the s5 system and gas blender and c5 system. The incident occurred in (b)(6). The affected part was returned to livanova (b)(4) for a detailed investigation. The investigator could not reproduce the reported issue. The gas blender worked according to specifications. A new calibration and a final technical safety check have been performed and the unit was returned to the customer. 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. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that an error code has been displayed on the gas blender system, which means a deviation from the set and the actual gas flow. The issue was detected during maintenance. There was no patient involvement.

• Brand Name: S5 SYSTEM AND GAS BLENDER AND C5 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: barbara galasso ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 8887250
• MDR Text Key: 175214550
• Report Number: 9611109-2019-00617
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/13/2019
• 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?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage