MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTICAL 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 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

(b)(4) received a report that the electrical venous occluder (evo) clamp did not properly restrict flow during a procedure.A hand tubing clamp was used to finish the procedure.There was no report of patient injury.

Manufacturer Narrative

The unique identifier (udi) number was not provided in the initial report.The udi of the reported device is (b)(4).(b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).The evo clamp was sent to livanova deutschland for further investigation and the investigator was able to reproduce the problem.The malfunction was traced back to the motor set current, which was set too low.After a new calibration of the device no further issue has been identified.The device was returned to the customer.A review of the dhr could not identify any deviations or noncomformities relevant to the reported issue.

• Brand Name: ELECTICAL 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 DETUSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6580060
• MDR Text Key: 75731730
• Report Number: 9611109-2017-00370
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/22/2017

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: 04/25/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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