MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 SCP ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP 500MM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-05-60

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report of a scp electrical remote-controlled tubing clamp 500mm not working during a procedure.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in united kingdom.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

The affected part was returned to manufacturer's site for a detailed investigation: the unit was disinfected, opened, cleaned, checked and tested.A loud noise was heard during erc opening and closing.To fix the issue, the motor area of the erc was cleaned, lubricated and greased.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2017.Based on investigation results and similar complaints, the reported event could be due to: - residues of dried fluids on the shafts, which obstruct the movements, generating noise; - wear of the unit ball bearing.

• Brand Name: S5 SCP ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP 500MM
• Type of Device: CONTROL, PUMP SPEED, 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: 16767216
• MDR Text Key: 313568192
• Report Number: 9611109-2023-00179
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900887
• UDI-Public: 010403381790088711180108
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/18/2023

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: 60-05-60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• 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