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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2022

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).It was reported that the customer had some issues with the device in the past and following to that the clamp was checked and found to be properly working.At the time, the device was re-calibrated and nvmem cleared.The device worked as per specifications and was returned to the customer.However, it was communicated that despite the clamp worked well for some time, there were errors sometimes during calibration and sometimes during work until recently reported error associated to the clamp encoder.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that electrical venous occluder (evo) gave some problems sporadically.Reportedly, the clamp displayed errors during calibration and also during use and recently gave an error code associated to the clamp encoder.There was no report of patient injury.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the customer only recall about error associated to the clamp encoder and not other errors.The affected device was returned to the manufacturer site for repair and upon testing the reported issue could not be reproduced.However, the clamp encoder and the ribbon cable were replaced as potentially involved components.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

Based on available information and similar reports from other customers, it cannot be ruled out that the most likely root causes was an intermittent faulty connection between the encoder board and the ribbon cable.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14373719
• MDR Text Key: 291491965
• Report Number: 9611109-2022-00241
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)170901
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• 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: 06/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2017
• 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