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	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: 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
Livanova deutschland received a report of a timeout of electrical remote-controlled (erc) tubing clamp, without being functional.Reportedly, the centrifugal pump drive experienced an internal control error during the event.The issue occurred during set-up of the device.There was no patient involvement.
Additional Manufacturer Narrative
H11: a livanova field service engineer (fse) was dispatched to the facility to investigate the device and could not confirm the reported issue.As preventive measure, the hkr electrical board was replaced.Unit was tested and found aligned with specification, thus it was returned back 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.

• 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 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23838518
• Report Number: 9611109-2025-90610
• Device Sequence Number: 9527594
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/26/2026

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: 620 MM
• Device Catalogue Number: 60-05-65
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/04/2026; 05/29/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/03/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown