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

Model Number 25-40-46

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 gas blender system. The event occurred in (b)(6). The device was sent to livanova (b)(4) for investigation. The service engineer inspected the device and was able to confirm the reported issue. During inspection the calibration showed a deviation in the o2 flow which was caused by a defective mass flow controller. After the replacement of the defective part, the device was re-calibrated and subsequent tests were performed successfully. A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Manufacturer Narrative

There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The event occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The device was returned to livanova (b)(6) where the issue was confirmed. The unit has been returned to livanova (b)(4) for further investigation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information relevant 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 had no oxygen flow. 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 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6956622
• MDR Text Key: 249469327
• Report Number: 9611109-2017-00823
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/11/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/17/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage