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

Model Number	SRD S5 ERC TUBING CLAMP 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	07/23/2025
Type of Reportable Event	Malfunction
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 tokyo, japan.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 that, during priming, the icon of an electrical remote-controlled tubing clamp (erc) disappeared from the cp5 control panel and clamp failure was displayed on the s5 system panel.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11.Livanova field service engineer was dispatched to customer facility.Upon device evaluation the issue was not reproduced but it was confirmed that the clamp control board will be replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Based on follow-up communications, livanova learnt that erc zka and zkb boards were replaced as a precautionary measure.A review of the service history for the affected device confirmed that the reported event represented the first occurrence associated with the specific unit involved.No concerning trend was reported related to this failure mode.As the reported event could not be reproduced during on-site testing, and based on the information currently available, the event is considered isolated, while the root cause of the occurrence could not be conclusively established.Nevertheless, taking into account the outcomes of previous investigations into similar events, it cannot be excluded that a temporary and non-persistent malfunction of an internal component, including one or both of the aforementioned boards, may be considered a potential contributing factor associated with the reported behavior.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See inital 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: 22836960
• Report Number: 9611109-2025-90316
• Device Sequence Number: 9548791
• Product Code: DTQ
• UDI-Device Identifier: 04033817901068
• UDI-Public: (01)04033817901068(11)160219
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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: SRD S5 ERC TUBING CLAMP 620MM
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 02/18/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/28/2025; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2016
• 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