MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 CONSOLE; 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	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the s5 console.A livanova field service engineer was dispatched the customer and disassembled the e/p pack.No issue was found.The s5 was disconnected and inspected in the system boards.The maintenance on the electrical connections was performed.Log files in attachment.Until now, the s5 was used as a backup in the hemodynamics room.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 a procedure, two roller pumps (rp150 and the drp85), were restarting themselves, and one was reporting errors, along with an anomaly on the control board.The drp85 displayed "short-term internal malfunction, remains operational - pump 5b" and "fault in motor controller pump (441) pump 5a"(pumps a and b respectively) the pump also restarted on its own several times without any error messages.During the same procedure, the rp150 suction pump restarted automatically without any error messages.The cp5 was on, and the main peristaltic pump rp150 (named heart 1) had been turned off (by the button since the s5 was turned on).However, the pump selection panel displayed "heart 1" on the pressure 1 display and no option to select this pump was possible.There is no report of any patient injury,.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: through follow-up communications, livanova learned that the ground cable was not used during the procedure.Read-out files (real-time device parameters and setting recording file) were gathered and analysed.All three affected pumps stored records software resets; in one case this was followed by the can timeout error (error 441 confirmed by pictures).In multiple cases, the time stamps were not stored; however, from events stored before and after the event, it is reasonable to assume that they occurred on the reported date.The software reset of s5 hlm is a designed protective function of the system, which prevents an exception in the information transmission on the can bus to propagate, thus affecting subsystem functionality.The signal on the can bus can be distorted by electromagnetic disturbances or also in case of microprocessor failure on electronic boards.If the reboot is delayed, the timeout can be detected by the system.Possible causes for a delayed reboot are a persistent interference on the can bus or worn electronics related to multiple and not deterministic factors.Based on the investigation findings, no device malfunction was detected.Thus, the root cause of the reported condition could be reasonably traced back to an electromagnetic interference, potentially deriving by the presence of high-frequency devices and with contribution of the absence of the potential equalization cable.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 CONSOLE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 23085523
• Report Number: 9611109-2025-90367
• Device Sequence Number: 21283373
• Product Code: DTQ
• UDI-Device Identifier: 04033817902676
• UDI-Public: (01)04033817902676(11)231025
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K210130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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