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

Model Number	48-40-00
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report that a s5 pump displayed an error related to encoder malfunction.The event occurred during a procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5.The incident occurred in usa.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a pump encoder even if the error was cleared during technical test.Therefore, the component was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: involved s5 was manufactured in 2019 and according to the analysis of the complaints database, no further events have been reported in the past.Based on the above facts and taking into account the investigation performed for similar events, the reported failure was traced to a defective shaft angle encoder.Wearing of electro-mechanical devices, that can be originated by the specific use conditions at customer's site, may have contributed to the event, however there is no concerning trend for this kind of failure.No specific action was currently deemed necessary, livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.
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; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19557045
• Report Number: 9611109-2024-00258
• Device Sequence Number: 20515893
• Product Code: DTQ
• UDI-Device Identifier: 04033817900894
• UDI-Public: (01)04033817900894(11)190314
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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
• Device Model Number: 48-40-00
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown