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 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Initial reporter telephone number: (b)(6).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 device has been requested for return to livanova (b)(4) for further evaluation.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 the s5 gas blender system displayed an error message during priming.There was no patient involvement.

Manufacturer Narrative

The initial reporter telephone number provided in the initial report, submitted august 16, 2017, was incorrect.The correct phone number is: (b)(6).

Manufacturer Narrative

The device was returned to livanova (b)(4) for further investigation.The reported issue could not be reproduced.During investigation, no error code was displayed.The service engineer performed a routine maintenance.A recalibration, a test run and a tsi check were performed without any issues and the device was returned to the customer by livanova (b)(4).

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• 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: 6799112
• MDR Text Key: 83849286
• Report Number: 9611109-2017-00637
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 11/26/2017
• Supplement Dates FDA Received: 08/16/2017; 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2006
• 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