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

Model Number 12-80-10

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the electrical venous occluder (evo).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 electrical venous occluder (evo) was alarming during procedure.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

Through follow-up communication livanova learned that due to covid-19 emergency and hospital restrictions it was not possible to perform a service activity.Reportedly, the reported issue no longer reoccurred.Based on previous investigation results, the most likely root cause is a mechanical lack of lubricant and inadequate cleaning by the user.This could not be confirmed.If any additional information pertinent to the reported event is received as well as service activity results, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: the serial number of the device was provided and the dedicated d.4 section has been updated accordingly as well as h.4.

Event Description

See initial report.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11064956
• MDR Text Key: 223773272
• Report Number: 9611109-2020-00710
• Device Sequence Number: 1
• Product Code: DXC
• 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,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12-80-10
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1