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

Model Number 25-40-46

Device Problem Gas Output Problem (1266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland 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 deutschland received a report of a s5 gas blender system 5l having divergence in fio2 and unstable flow during priming.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that an error message was displayed.In addition, it was learned that the co2 value of the gas blender fluctuated constantly and was not staying at the preset value.The device was removed from service and customer was provided with a replacement unit.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: the affected device was received at the manufacturer site for repair.However, upon functional test the device was found to be working within specifications and no deviation could be found.Calibration will be performed and activity is pending customer approval.Based on all the above facts, the most likely root cause of the reported event is traced back to an improper hospital gas supply.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the device was calibrated, cleaned and disinfected.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

• 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: 12801975
• MDR Text Key: 282737797
• Report Number: 9611109-2021-00645
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-46
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2010
• 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