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

Model Number	60-05-60
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
See initial report.
Additional 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
• Common Device Name: 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
• Report Number: 9611109-2023-00179
• Device Sequence Number: 3252328
• Product Code: DWA
• UDI-Device Identifier: 04033817900887
• UDI-Public: 010403381790088711180108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 60-05-60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 07/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown