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

Model Number	SRD S5 CONSOLE FOR 4 PUMP
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report about an s5 hlm system showing a motor controller failure error message and inconsistent direction of rotation.The issue occurred during priming.There is no report of any patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11: livanova deutschland manufactures the s5 hlm system, the event occurred in india.Livanova has initiated an investigation.If any additional information is received, a follow up report will be submitted.
Additional Manufacturer Narrative
H11: through follow-up communication it was confirmed that the error message was a motor control failure (e442) which indicates that the speed set value is different than the actual value.If any additional information is received, a follow up report will be submitted.
Event or Problem Description
See initial report.

• Brand Name: S5 HLM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHLAND; 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 80004
• MDR Report Key: 24510619
• Report Number: 9611109-2026-90072
• Device Sequence Number: 10456679
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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 CONSOLE FOR 4 PUMP
• Device Catalogue Number: 48-40-00
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/01/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown