MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP; CONSOLE, HEART-LUNG MACHINE, 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	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the electrical remote-controlled tubing clamp.Based on device investigation, more than 50% of parts should be replaced to make the clamp functioning again.The erc clamp was manufactured on 2017.Customer will be asked if the clamp has to be return to his site to be scrapped or if it is possible to scrap it directly in the factory.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that the erc clamp was making noise during procedure.There is no report of any patient injury.The device was investigated and it was clarified the alarm 'arterial clamp is defective' was displayed, with no possibility to operate the clamp.Therefore, the complaint from the customer is confirmed.Investigation found corrosion on the can cable, lightbarrier cable and control board.The spindle was blocked inside the clamp head (this is probably the reason why the customer heard noise).
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: the involved clamp was manufactured in 2017 and according to the analysis of the complaints database no further events have been reported in the past related to this unit.Taking into account the investigation's results of previous similar complaints, livanova technical inspection and considering the manufacturing year of the claimed unit (2017), the issue can be due to: residues of dried fluids on the shafts, which obstruct the movements and generated noise; wear of the unit ball bearing.The wearing of electro-mechanical device can be originated by the specific use conditions at customer¿s site and may have contributed to the event.
Additional Manufacturer Narrative
Based on the collected information the most likely root cause of the reported issue is wearing of the unit, likely due to age.The wearing of electro-mechanical device can be originated by the specific use conditions at customer's site and may have contributed to the event; however, there is no concerning trend for this kind of failure.Customer agreed to scrap the device.
Event or Problem Description
See intial report.

• Brand Name: ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich, germany 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21685481
• Report Number: 9611109-2025-00120
• Device Sequence Number: 21152674
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)171218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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
• Was Device Available for Evaluation?: Yes
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 05/02/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025; 05/28/2025
• 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