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

Model Number	SRD S5 ERC TUBING CLAMP/500MM
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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 (b)(6), california.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 an electrical remote-controlled tubing clamp was not working.The issue occurred during procedure.There is no report of patient/user injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11 no service activity was requested by the customer.A review of the device¿s service history confirmed that no similar events have been reported since the date of manufacturing.Statistical analysis conducted over the last 12 months does not show any trend or evidence of a recurring or systematic product issue associated with this failure mode.Based on the investigation of similar cases and considering that no service intervention was requested, no hardware malfunction occurred and it cannot be excluded that the event was due to a temporary device malfunction or user perception.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 GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24398519
• Report Number: 9611109-2026-90057
• Device Sequence Number: 8158839
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 08/09/2017
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown