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

Model Number 12-80-10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).The affected device was returned back to the manufacturer site for investigation.Results did not confirm the reported issue.The device was found to be working according to the specifications.However, some components will be replaced as precaution.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

Livanova (b)(4) received a report that a electrical venous occluder (evo) displayed an error code during priming.There was no patient involvement.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9225625
• MDR Text Key: 195721122
• Report Number: 9611109-2019-00839
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082344
• 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
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12-80-10
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2010
• 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