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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

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).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.When the flow rate was tested at (air + o2)= 0.3 lpm, fio2 reading was low and display became erratic.A replacement device has been provided to the customer and the affected unit will be returned to manufacturer for repair.The device will be sent to the manufacturer site for repair.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 of inconsistent/erratic flow on a s5 gas blender system during procedure when flow rate is low.Reportedly, there was poor fio2 control at low flow rates.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: the affected device was returned to the manufacturer site for repair and no failure could be found during tests.The device was functioning properly according to specifications.Subsequent functional verification testing was completed without further issues and the unit was returned to service.According to device instruction for use, the device can be operated above an operating curve.If the customer had set the gas blender in such a way that the internal mass flow controllers were on their operating limit, any setting below the line reported in the ifu is uncertain and device cannot guarantee technical flow accuracy/limit of the mass flow controller.Therefore, it cannot be excluded that a user error may have contributed to the reported issue.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13058647
• MDR Text Key: 285359534
• Report Number: 9611109-2021-00714
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/22/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• 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