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 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 gas blender system.The incident occurred in pleasant prairie, wisconsin.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a s5 gas blender system gave an error code associated to a discrepancy between the actual and set gas flow values during setup.There was no patient involvement.

Manufacturer Narrative

Livanova received report a stating that the electronic gas blender (egb) displayed the error code e19, associated to a discrepancy between the set and the actual gas flow values.The error appeared when turning the co2 up to 1.00 l/min flow.There was no patient involvement.The issue was identified during the test at the customer site after returning the device from manufacturer's site due to a similar event.The affected device was returned back to the manufacturer site for repair.The device was opened, checked and cleaned.The reported issue was reproduced and the error e19 was displayed for a co2 setting of 0.85 to 1 l/min.The mass flow controller for co2 (pn 73-300-253) and the relative flow sensor (pn 73-300-140) were replaced by the technician.Calibration performed, preventive maintenance and test completed with positive results.Unit returned to customer the involved gas blender was manufactured in 2008 and according to the analysis of the complaints database no further event was reported since installation.Based on similar investigations reviewing the complaint database and investigation results, a deviation in the component found defective cannot be excluded.In detail, sensors drift could have led to inaccurate (co2) flow measurement readings.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• 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: 15426800
• MDR Text Key: 300073602
• Report Number: 9611109-2022-00463
• Device Sequence Number: 1
• Product Code: DWC
• 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: 12/07/2022

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: 08/17/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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