MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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 Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The affected device was requested back to the manufacturer site for investigation.Results confirmed the reported issue and functional tests revealed an error code outbreak associated to the reported discrepancy between the actual and set values of o2 output.The issue was traced back to a defective o2 honeywell sensor.This part will be replaced as well as three (3) cables harness for air/o2/co2 which will be replaced as precaution.

Event Description

Livanova (b)(4) received a report of a discrepancy between the set and the actual oxygen (o2) output values on a s5 gas blender system.The issue was identified during maintenance activity.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 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 10090647
• MDR Text Key: 194051385
• Report Number: 9611109-2020-00318
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2006
• 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