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

Model Number 25-28-67

Device Problem Gas Output Problem (1266)

Patient Problem Hypoventilation (1916)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).Livanova initiated an 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 a s5 gas blender system was used during a cardiac surgery on (b)(6) 2021.Reportedly, the pco2 value remained high despite user increasing the air/o2 flow to 4 liter/minute.The device was replaced with another and the user decreased the air/o2 flow rate and the pco2 value decreased to normal values.The immediate postoperative period was marked by hypoxemia with alveolar hypoventilation.The patient was released from hospital on (b)(6) 2021.

Manufacturer Narrative

H10: a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected device was returned to the manufacturer site.No errors and no deviations could be identified.However, the potentially involved component which is the mass flow controller for co2 was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The involvement of the device cannot be ruled out and the most likely root cause of the event was a defective co2 mass flow controller.

Event Description

See initial report.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• MDR Report Key: 11628194
• MDR Text Key: 256516758
• Report Number: 9611109-2021-00176
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-28-67
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other