MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND (01)04033817901068(11)180806(21)60S22986; 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	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova deutschland manufactures the erc, the event occurred in united states.Livanova field service engineer confirmed the issue, and to solve it, the affected device has been replaced with a new clamp.A review of the device¿s service history confirmed that no similar events have been communicated to livanova since manufacturing date.A review of complaints database did not identify any trends associated with this type of fault.Based on the available evidence, the most likely root cause is associated with progressive wear of the electro mechanical device.This wear could have been initiated or accelerated by specific use conditions at the customer site, including situations that may be unintended, occasional, or not consistently repeated such as unexpected movements or accidental liquid penetration that can produce cumulative effects over time.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
Livanova deutschland received a report that the electronic remote clamp erc installed on s5 hlm system showed an error message indicating that the device was defective.There was no patient involvement.

• Brand Name: (01)04033817901068(11)180806(21)60S22986
• 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
• MDR Report Key: 24470077
• Report Number: 9611109-2026-90067
• Device Sequence Number: 18699593
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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
• Device Model Number: SRD S5 ERC TUBING CLAMP 620MM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Initial Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 08/06/2018
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown