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

Model Number	620 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	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an electrical remote-controlled tubing clamp (erc) had a failure during service activity.In detail, the clamp icon disappeared from the cp5 control screen.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 (b)(6) spain.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova deutschland for a detailed investigation.The technician could confirm the reported issue: clamp is not recognized by the system.In order to solve the issue, zak board will be replaced upon customer's approval.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.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Device was returned to manufacturer for repair.Upon inspection, issue was confirmed: the clamp was not recognized by the system.As troubleshooting the zka board was replaced.Functional checks device was returned to manufacturer for repair.Upon inspection, issue was confirmed: the clamp was not recognized by the system.As troubleshooting the zka board was replaced.Functional checks passed positively and unit has been returned to service.A device service history review has been performed and identified that the unit was manufactured in 2021 and no other similar event has been reported, neither concerning trend has been identified.Based on the outcome of service activity, the root cause of the reported issue has been assigned to an electrical failure of the zka board.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro subcomponents.However, there is no concerning trend for this kind of failure.Livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.

• Brand Name: ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22103385
• Report Number: 9611109-2025-90153
• Device Sequence Number: 7276076
• Product Code: DTQ
• UDI-Device Identifier: 04033817901068
• UDI-Public: (01)04033817901068(11)211102
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2025

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: 620 MM
• Device Catalogue Number: 60-05-65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 09/02/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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