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 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 clamp was received at livanova japan and there was no reproduction of the reported issue.After technical analysis of the reported issue, it was concluded the dashes were not referring to the % of clamp opening as reported initially and that dashes appeared near the "%" symbol, indicating that the clamp may have been unplugged or defective.Functional tests performed revealed that the clamp worked properly and no problem could be found suggesting a connection issue between the occluder and its panel.An issue impacting closing/opening functions cannot be completely excluded.Therefore, as a conservative approach, this is considered a reportable event.The evo control panel was checked and there was no abnormality.The connector between the panel and the occluder was reconnected.The nvmem (memory) of the clamp was cleared and calibration and closing force adjusted by flashing new software revision.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

Livanova (b)(4) received a report that an electrical venous occluder (evo) displayed an error during circuit blood collection after the pump operation was completed.Reportedly, the error number was not displayed and only dashes appeared in the % of the opening display section.There was no report of patient injury.Furthermore, it was reported by the user that prior to this event, an error was previously displayed at the power up.The user turned off and back on the device twice with no improvement of the issue and 100% display appeared at the third time.Thus, the customer monitored the device for a while.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• 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: 13903054
• MDR Text Key: 287910910
• Report Number: 9611109-2022-00127
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)160905
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/25/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2016
• 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