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

Catalog Number 12-80-10

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

Livanova received report that a electrical venous occluder (evo) gave an error (ee1538) code associated to the clamp encoder during priming.There was no patient involvement.

Manufacturer Narrative

"there was no patient involvement.Livanova deutschland manufactures the electrical venous occluder (evo).The incident occurred in (b)(4).A livanova field service engeneer was dispatched the customer and the reported condition was confirmed: error message 1538 confirmed.The device has been functionally checked.The step screw, the env encoder board and ribbon cable were renewed.The clamp and hose have been calibrated, flash update performed and error memory cleared.The device was tested and returned successfully to customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.".

Manufacturer Narrative

H10: based on troubleshooting results and available information, the root cause of the reported event was traced back to defective encoder board and ribbon cable.

Event Description

See initial report.

• 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: 15109648
• MDR Text Key: 296708401
• Report Number: 9611109-2022-00365
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12-80-10
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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