MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SCP WITH TUBING CLAMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-65

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a repor that the elctronic remote clamp had an errore during a procedure.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in united states.A livanova filed service engineer was dispatched to the customer site.The complained erc engage/close on its own not reproducible.The device was replaced with another one.Functional checks were successfully completed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

The unit has been installed since 2014 and an analysis of the complaints database did not reveal further reported incidents.The most likely root cause of the reported issue are: defective internal board resulting in an intermittent failure or faulty communication between the mentioned erc and the related s5 console.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event, the risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: SCP WITH TUBING CLAMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17681065
• MDR Text Key: 322632362
• Report Number: 9611109-2023-00415
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• 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: 11/14/2023

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: 60-05-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1