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

Model Number	48-30-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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 (b)(6) in order to try to solve the issue, electronics and power (e/p) pack was replaced with a loan unit, however this did not fix the issue.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 the cardioplegia blood pump rotated only a quarter turn and then stopped (while the re-circulation button was enabled on the cardioplegia screen).No additional information was received.
Additional Manufacturer Narrative
H11: following customer information, livanova has been informed that serial read out from cardioplegia pump and arterial pump has been provided to be investigated.In addition, no cardioplegia dose was set that could have stopped the pump.Error message "no monitoring/control pump 3b" was displayed on cardioplegia pump, and no information about which module failed was provided.However the cardioplegia pump was stop linked to the arterial pump which was controlled by other sensor modules that showed errors.Console was inspected by authorized technician, monitoring alarms were reproduced, first related to level, then occurred on pressure.After replacing the ep pack and sensor modules (level, pressure, bubble and cardioplegia, the system worked properly.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.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: preliminary technical inspection of the pump and the entire s5 console confirmed no issue with the pump.However, both when the issue occurred and during technical inspection, several issues were noticed such as failure of level monitoring function, heater cooler connected started pumping without being instructed so, bsa calculation not working, level sensor monitoring failed and alarms not clearing.Reportedly, the cardioplegia pump was stop-linked to the arterial pump, therefore it is reasonable to assume that the stop was controlled by the master-slave link established.Taking into account that several issues were reported, it was assumed that the root cause was most likely related to the interference from some module.Despite testing, no specific component was found faulty.Since replacement of ep pack with a loaner did not solve the various issues, several modules (level, bubble, pressure, temperature, cardioplegia and b-care) were replaced and after that the unit passed tsi checklist and was release to service.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar event has been reported.After about a month some minor issues reoccurred regarding the monitoring functions and the acknowledge of alarms.Therefore, the electronics and power (e/p) pack and arterial pump were then returned to manufacturer, while the cardioplegia pump was kept at customer site since field service technician excluded any malfunction.Technical inspection of the returned arterial pump and electronics and power (e/p) pack performed at manufacturer confirmed that ups module was defective and preventing the batteries from being charged properly.No interference was confirmed from any of the returned modules: all modules worked correctly, all settings could be changed, warning alarm or stop-link function with the pump were working properly.Error message "no monitoring/control on pump1" was correctly displayed when disconnecting the sensor modules and could be cleared.Arterial pump was found properly working, no error messages were displayed, pump run smoothly, all the setting can be changed and saved in the menu and it properly reacted to alarm and warning conditions (open cover, level sensor, pressure sensor, bubble sensor,.).However, signs of corrosion were detected on both sides of the power cable of the arterial pump returned, and may have caused some interference with the can bus.Arterial pump was then tested and no error messages were displayed when turned on.Pump run smoothly and all settings can be changed in the menu.Pulse-mode also tested and working fine.Pump properly reacted to alarm and warning conditions (open cover, level sensor, pressure sensor, bubble sensor,.).Analysis of log file provided confirmed no data stored for date of event, but data was present from two days after, therefore it is likely that the logs were overwritten due to limited memory and use.For cardioplegia pump logs it was confirmed several alarm indicating that the master pump stop-linked to the cardioplegia pump failed or was switched off.Regarding the arterial pump logs were confirmed lost links with several sensors, most likely occurred during field service activity of electronics and power (e/p) pack replacement reported.In addition, on both pumps there was a message indicating that system detected several errors and the can controller would not send/receive anything for a while and an error was stored indicating ¿ups defective or not present¿ that may be due to faulty can, e.G.Due to short circuit.According to information provided by field service technician, no cardioplegia dose was set that could have stopped the pump.The error message "no monitoring/control pump 3b" was displayed and taking into account log files analysis it was most likely related to the list link with arterial pump.Based on the fact that the cardioplegia pump was stop-linked to the arterial pump which was controlled by other sensor modules that showed errors, it is reasonable to assume that the pump was stopped by the stop-link and after that the link failed, displaying the "no monitoring/control pump 3b".Taking into account that several failures occurred together and upon inspection of electronics and power (e/p) pack and roller pump no sensor modules issue was reproduced, it cannot be ruled out that a can disturbance/failure may have caused the reported issues.Based on the technical inspection, can disruption may have been affected by the corrosion/oxidation on the roller pump cable with possible contribution of the ups module failure.Electronics and power (e/p) pack and pump are currently in livanova deutschland for repair.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19803408
• Report Number: 9611109-2024-00327
• Device Sequence Number: 18218327
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: (01)04033817900887(11)181123
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2024

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: 48-30-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 11/14/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/21/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2018
• 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