MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	SRD S5 CONSOLE FOR 4 PUMP
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 pump gave a motor controller fault error message (442 code) during priming.There was no patient involvement.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the s5 system.The incident occurred in india.As troubleshooting at customer's facility motor control board (hms) was replaced with a new one, however the issue remained.No foreign objects / tight occlusion was found in the pump head.Pump did not freely rotate when switched off and this behaviour was intermittent.Error code 442 is likely related to resolver issue.Therefore, the affected pump will be shipped to livanova deutschland for a detailed investigation and repair.Meanwhile, new pump has been ordered as replacement.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11.Device was investigated at manufacturing site: it was tested and reported error was not confirmed.Functional test was performed and no parts were replaced.A device service history review has been performed and identified that no other similar event has been reported, neither concerning trend has been identified since manufacturing date.Based on all the gathered information and taking into account that no fault in the pump was found, it cannot be excluded that the issue may have been due to user error in setting the occlusion too tight, using the wrong tubing, or a foreign object in the pump rotor that should have been checked by the user before starting the procedure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 SYSTEM
• 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: antonella donatiello ; 14401 w. 65th way; arvada, CO 15238
• MDR Report Key: 22466543
• Report Number: 9611109-2025-90243
• Device Sequence Number: 20856439
• Product Code: DTQ
• UDI-Device Identifier: 04033817902676
• UDI-Public: (01)04033817902676(11)230214
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K210130
• 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
• Report Date (Section B): 12/05/2025

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 CONSOLE FOR 4 PUMP
• Device Catalogue Number: 48-40-00Z
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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