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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11: livanova deutschland manufactures the s5 system.The event occurred in india.The motor controller pcb has been replaced, and the unit is currently under observation.If any additional information is received, a follow up report will be submitted.
Event or Problem Description
Livanova deutschland received a report regarding an s5 heart-lung-machine that showed a motor controller failure error.The issue occurred during priming.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: through follow-up communications, it was confirmed that the error message was a motor control failure (e442) which indicates that the speed set value is different to the actual value.A device service history review has been performed and identified that no other similar event has been reported since unit installation, neither concerning trend has been identified.Based on the investigation findings, the root cause of the reported failure has been assigned to an electrical failure of the motor controller (hms) board.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impact (drops and falls), and power overloads/surges but also to variability of micro subcomponents.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: 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: 24510882
• Report Number: 9611109-2026-90071
• Device Sequence Number: 21322070
• 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: 04/03/2026
• Date Device Manufactured: 06/14/2017
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown