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

Model Number 25-40-45

Device Problem Incorrect Measurement (1383)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The device was requested back to livanova (b)(4) for investigation and repair.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 a s5 gas blender system displayed wrong values during priming.There was no patient involvement.

Event Description

Livanova deutschland received a report that a s5 gas blender system displayed wrong values during priming.There was no patient involvement.

Manufacturer Narrative

The complained unit has been received in livanova deutschland for further investigation.A functional test has been carried out.Results revealed that the reported event could not be reproduced.The device has been opened and visually inspected.No deviation could be found.As the reported malfunction could not be confirmed, the root cause of the event could not be identified.

• 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
• MDR Report Key: 7892764
• MDR Text Key: 120831727
• Report Number: 9611109-2018-01236
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1