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

Model Number 25-40-45

Device Problem Gas Output Problem (1266)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Date of event is unknown.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).Through follow-up communication livanova (b)(4) learned that the issue was not reproducible.The affected device has been requested back to the manufacturer site for further investigation.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 an error code associated to a discrepancy between the effective gas output value and the set one was displayed on a s5 gas blender system during priming.There was no patient involvement.

Manufacturer Narrative

H.10: the affected device was requested back to the manufacturer site for a detailed investigation.Results revealed that the reported failure could not be confirmed.The device was found to be properly working.However, the power harness cables for air/o2/co2 will be replaced as precaution and a re-calibration of the device will be carried out.

Event Description

See initial report.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9568284
• MDR Text Key: 179415048
• Report Number: 9611109-2020-00009
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1