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 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the electrical venous occluder (evo).The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication with the customer, livanova (b)(4) learned that no errors were displayed during the incident.A loaner has been requested.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 submitted in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that the electrical venous occluder (evo) let blood through on the venous side when set to fully occlude.There was no report of patient injury.

Manufacturer Narrative

A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to reproduce the reported issue.The device was not made available for investigation at livanova (b)(4), so further investigation could not be performed.The customer has not reported any further issues with the device.The issue described is a known issue.Corrective actions are in progress.Evaluated on site by livanova technician.

• 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
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6852521
• MDR Text Key: 86288000
• Report Number: 9611109-2017-00699
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K082344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2011
• 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