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

Model Number	48-30-00
Medical Device Problem Codes	No Audible Alarm (1019); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the sorin s5 system.The incident occurred in germany.A livanova field service representative was dispatched to the facility to investigate the device.According to customer information, the issue is a sporadic error, no acoustic alarms (entire hlm), alarm only occurs visually.The alarm displayed was not reported and it is unknown.The console was tested, checked of all alarms (return after muting, high and low priority), plug connectors checked, recording carried out using pcan explorer, no error messages found on the can bus.The fault complained about could be resolved within 3 hours.Test run cannot be reproduced.Test run ok and no spare part was requested.Unit returned to customer.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 has received a report that, during priming, the s5 console displayed visual alarm and no acoustic alarm.Medical team switched the machine off and on and it worked for a while; then no acoustic alarm was heard again.There was no patient involvement.
Additional Manufacturer Narrative
A livanova field service engineer (fse) was dispatched on-site and confirmed the reported issue.The fse troubleshot on-site and checked all the involved connections and was able to solve the issue without any parts replacement.Mechanical/electrical checks and functional testing were performed and passed successfully, therefore the unit was put back into regular service.The complaints database review pointed out that no further similar issue has been submitted for this unit since its installation in 2017.Based on the above facts, the root cause of the reported case is an electrical failure, as bad/loose connections, a false contact or some oxidized electronics that were reestablished and solved by the technician during service intervention.Missing alarm sound is not likely to result in serious injury or death since does not prevent visible alerts/messages on the pump/system panel display allowing user to realize the alarm situation and does not impair safety measures (e.G.Clamp closure, pump stop) and functionality of the s5 system.Therefore, the event has been reassessed as not reportable.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: SORIN S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18500787
• Report Number: 9611109-2024-00027
• Device Sequence Number: 12793610
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: (01)04033817900887(11)171120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2017
• 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