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

Model Number	620MM
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a defective electrical remote-controlled (erc) tubing clamp.An error message was displayed onto the heart-lung machine unit.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: 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: through follow-up communications, it was learned that the device was returned to manufacturer: the issue was reproduced and confirmed.Due to the aging of the device, repair was not recommended and device was scrapped.A device service history review has been performed and identified that the unit was manufactured in 2017 and two similar events have been reported in the past.Based on the investigation findings and device history review, the most likely root cause of the reported event is a blocked spindle, probably due to dried fluid residues accumulated over time due to improper cleaning of the device.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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): LIVANOA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23826017
• Report Number: 9611109-2025-90599
• Device Sequence Number: 8954683
• Product Code: DTQ
• UDI-Device Identifier: 04033817901068
• UDI-Public: (01)04033817901068(11)171130
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 620MM
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown