MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ERC TUBING CLAMP / 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-65

Device Problems Communication or Transmission Problem (2896); Difficult to Open or Close (2921)

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

Event Date 02/24/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 erc (electrical remote-controlled) tubing clamp / 620mm not sensing properly and gave an error message.The issue occurred during procedure.There was no patient injury.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 erc tubing clamp / 620mm.The incident occurred in (b)(6).Livanova initiated an investigation.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

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2012.No service activity was performed on-site and a new erc has been ordered by the customer.However, based on investigation results of previous similar cases and on the manufacturing year of the device (2012), the reported issue can be traced back to wear.

• Brand Name: S5 ERC TUBING CLAMP / 620MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16608626
• MDR Text Key: 312136128
• Report Number: 9611109-2023-00117
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• 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
• Report Date: 03/24/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2012
• 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