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

Model Number	48-30-00
Medical Device Problem Code	Failure to Auto Stop (2938)
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 arterial pump did not stop, despite being selected as controlled pump, when high arterial pressure alarm was created.No additional information was received.
Additional Manufacturer Narrative
Throught follow up livanova was informed that "no monitoring/control pump 1" appeared on arterial pump for pressure control during testing.According to product ifu, if this occurs during procedure, the pump continues running and the connection between the monitoring unit and the pump is interrupted (the icon for monitoring function on the pump display goes out).It cannot be excluded that the pressure monitoring function failed during operation and therefore pump did not stop when the high pressure alarm was created.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H 11: preliminary technical inspection of the pump and the entire s5 console sn: (b)(6) confirmed the appearance of "no monitoring/control on pump1" related to pressure module/sensor.However, both when the error occurred and during technical inspection, several issues were noticed: failure of level monitoring function.Heater cooler connected started pumping without being instructed so bsa calculation not working.Level sensor monitoring failed.Alarms not clearing.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 issue, 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 (#: 2024-05576) and the ep pack and arterial pump 50e02057 were then returned to munich for investigation and repair.Technical inspection of the returned devices performed at tssi workshop confirmed that ups module was defective and preventing the batteries from being charged properly, but 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 2 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 1d5h=timeout_intervention 0001h 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 ep 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.Regarding the arterial pump not stopping in case of arterial pressure alarm, technician on site confirmed that during inspection the "no monitoring/control pump 1" was reproduced with pressure monitor, therefore the pump did not stop in case of alarm due to the failure of the monitoring function.As per ifu, in case of failure during operation the pump continues running and the function can be reactivated in system menu; procedure can be completed taking extra care without the control or monitor function if this cannot be reactivated.Taking into account that several failures occurred together and upon inspection of ep 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.Ep pack and pump are being repaired.
Event or Problem Description
See initial report.

• Brand Name: S5 MAST ROLLER PUMP
• 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: 19790300
• Report Number: 9611109-2024-00324
• Device Sequence Number: 17920700
• Product Code: DTQ
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)181115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/10/2024

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
• Device Catalogue Number: 10-88-00
• 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: 07/22/2024
• Supplement Report FDA Received Date: 08/19/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2018
• 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