MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	500 MM
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an electrical remote-controlled tubing clamp (erc) was not able to open and to close during a repair activity.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the electrical remote-controlled tubing clamp.The incident occurred in ljubljana, slovenia.During repair activity performed by a livanova technician, it was found that the motor unit was blocked inside the metal housing and also error code e106 ("the motor is jammed") was displayed when trying to operate the clamp with the corresponding open/close buttons.In addition, high level of fluid penetration was detected inside the clamp which requires the replacement of several parts: adapter for quick clamp, photo sensor, stator with sensor board, spindle complete with block, flat washer, spring washer, bearing scp, groove ball bearing, clamp housing rear, printed circuit (pcb) zka and zkb boards.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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
H11: a device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar event has been reported, neither concerning trend has been identified.Based on all the collected information, the root cause of the reported event has been traced back to defective components likely due to fluid penetration into the erc clamp.

• 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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20637951
• Report Number: 9611109-2024-00531
• Device Sequence Number: 20675004
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)180208
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 500 MM
• Device Catalogue Number: 60-05-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2018
• 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