MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL REMOTE-CONTROLLED TUBING 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	05/28/2025
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 (b)(6).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 post-procedure.There was no patient involvement.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova deutschland for a detailed investigation.The technician could reproduce the reported issue: error message "arterial clamp defective" was displayed, with no possibility to control the clamp (open/close buttons not shown).Inspection of the device revealed a high level of fluid penetration in the overall clamp, with corrosion and crystalloids, metal plate for the board was completely covered with broken screws stuck inside, corrosion on the motor and stator plus spindle were blocked inside the clamp head.In addition, it is highly probable that also the boards got damaged from the fluid penetration.Device cannot be repaired and it is likely that device will be scrapped by customer.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 information.
Additional Manufacturer Narrative
H11: through follow-up communication it was confirmed that the unit has been scrapped.A device service history review has been performed and identified that the unit was manufactured in 2022 and no other similar event has been reported, neither concerning trend has been identified.Based on all the gathered information, the most likely root cause of reported event has been assigned to improper user cleaning and maintenance of the device, leading to fluid penetration into the clamp at the point that all internal components were highly damaged.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 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): LIVANOA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22307211
• Report Number: 9611109-2025-90196
• Device Sequence Number: 20974380
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 02/05/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/04/2025; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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