MAUDE Adverse Event Report: LivaNova Deutschland ERC Clamp; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	SRD S5 ERC TUBING CLAMP/500MM
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report about an error message indicating a defective erc clamp during procedure.There was no patient impact.
Additional Manufacturer Narrative
A1-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.

• Brand Name: ERC 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: 50752935
• Report Number: 9611109-2026-90426
• Device Sequence Number: 9148824
• Product Code: DTQ
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)161128
• 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
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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/500MM
• Device Catalogue Number: 60-05-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 11/28/2016
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown