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

Model Number 25-40-45

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

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).The customer reported that the device has undergone various repairs at livanova (b)(4).However, due to the intermittency of the reported issue, the reported problem has not been resolved.The customer believes the issue is more prominent after a cold start and goes away after a while.The device has been requested for return 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.Not returned to manufacturer.

Event Description

Livanova (b)(4) received a report that the s5 gas blender system has had intermittent error and alarm issues over the past several months.There was no report of patient injury.

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).The unit was returned to livanova (b)(4) for investigation and repair.Inspection of the device was able to reproduce the described error.During evaluation, the air and co2 gas controllers were found to require replacement.The parts were replaced and the unit was reassembled and tested.Functional verification testing was completed without further issues and the unit was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• 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: 6415631
• MDR Text Key: 70341230
• Report Number: 9611109-2017-00256
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1