MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 12-80-10

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative could confirm the reported issue.The root cause could not be identified.The evo was replaced.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.Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that the electrical venous occluder (evo) closed to 60% of the total occlusion without any user action during a procedure.There was no report of patient injury.

Manufacturer Narrative

The electrical venous occluder (evo) clamp was returned to livanova (b)(4) for investigation and repair.During the investigation a livanova service engineer inspected the device and was not able to confirm this issue.The motor current was adjusted and a new pinpoint calibration was performed.Subsequent functional verification testing was completed without issues and the unit was returned to service.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7196465
• MDR Text Key: 98048568
• Report Number: 9611109-2018-00041
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• UDI-Public: 010403381790050411171023
• Combination Product (y/n): N
• PMA/PMN Number: K082344
• 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: 03/09/2018

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: 12-80-10
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1