MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the gas blender system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and the issue could be confirmed.Livanova (b)(4) requested the affected device back for a detailed investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 gas blender system shown an error message during service.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: the unit was requested by livanova deutschland for a further and detailed investigation.No errors occurred during the test and no deviations could be detected.The reported malfunction could not be reproduced.Based on the above, the root cause of the reported event could not be determined.Since the error was reproduced during the visit of the field service representative at the customer's site and not during the intensive tests at livanova deutschland, it is reasonable to think that the issue is not device-related, but could be due to the hospital gas supply.According to the instruction for use, a minimum pressure of 2 bar per connection should be observed.Indeed, input pressure too low can cause a discrepancy in the target and actual values, leading to the reported error code.

• Brand Name: S3 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8888900
• MDR Text Key: 175224650
• Report Number: 9611109-2019-00620
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1