MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND E/P PACK; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	S5 E/P PACK
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 system.The incident occurred in japan.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 during procedure all roller pumps of a s5 console were turned off and on by themselves.The procedure was then completed without any problems.There was no patient injury.
Additional Manufacturer Narrative
H11: through follow-up communication, livanova learned that s5 system panel was properly working when the problem occurred.In addition, it was confirmed that a potential equalization cable was not installed.As per s5 hlm instruction for use, it is strongly recommended to check the operating theatre and the ambient of the operating theatre for emissions of high frequency emitting devices and to always have connected the potential equalization cable to earth.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 report.
Additional Manufacturer Narrative
H11: following the cleaning and disinfection process, the device was tested, and the reported event could not be reproduced.After performing all the functional tests with positive results, unit was sent back to customer in its expected functions.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 report.
Additional Manufacturer Narrative
H11: the affected ep pack was tested at manufacturing site, without finding any issue.After performing all the functional tests with positive results, the ep pack was sent back to customer in its expected functions.Log files gathered from s5 hlm roller pumps were analysed, reporting watchdog reset and can-bus interruption.The watchdog reset is a designed protective function: if the system detects an exception on the can bus signal, it performs a reset to prevent the exception to propagate and affect subsystems functionality.Can-bus timeout message indicates that the connection of the can bus to the pump has been temporary interrupted by an exception, and therefore the pump cannot be controlled by the hlm system.Based on full system product analysis, a hardware failure can be excluded.Considering that, according to s5 hlm instruction for use: a potential equalization cable must be connected to earth and, if it is essential to use the s5 system very close to other electrical equipment, it is prudent to determine, by observation, if the performance of either product is affected by unintended electromagnetic coupling (i.E.: high frequency devices in use in the operating room), this case was re-evaluated as not reportable, since no livanova device malfunction occurred.The most likely root cause of the event can be traced back to user error leading to an external interference from an high frequency unknown device.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: E/P PACK
• 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: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22069798
• Report Number: 9611109-2025-90136
• Device Sequence Number: 9338172
• Product Code: DTQ
• UDI-Device Identifier: 04033817900832
• UDI-Public: (01)04033817900832(11)180820
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/17/2026

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: S5 E/P PACK
• Device Catalogue Number: 28-98-00
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 11/10/2025; 01/20/2026
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/09/2025; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2018
• 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