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

Model Number 25-40-45

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). A review of the dhr could not identify any deviations or nonconformities relevant to the issue a field service technician was dispatched to the facility to investigate the device and was not able to reproduce the reported issue. He tested the unit and when the flow rate of o2+ air fell below the set value the alarm properly worked. As results of the service activity no abnormalities were found. Based on the information available, it cannot be ruled out that a user error during the set-up phase led to the reported issue.

Event Description

Livanova received a report stating that no alarm sounded when the o2 and air connectors were removed from the s5 gas blender. The issue occurred during set-up after the setting of the output value. 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 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 10090651
• MDR Text Key: 194051938
• Report Number: 9611109-2020-00321
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/27/2020
• 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: 04/01/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse