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

Model Number	48-40-00
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova maintains dhr documentation for each device that for release to use shall be manufactured in accordance with the dmr and the design requirements.For this specific case it is not deemed necessary to perform dhr review because potential root causes cannot be related to a manufacturing issue.Livanova initiated an investigation.If additional relevant information will be available a follow-up report will be submitted.
Event or Problem Description
Livanova received a report about a pump alarm "fault in motor controller (431)".Even after switching off/on multiple times - pump not revolving.No patient impact reported.
Additional Manufacturer Narrative
H 11: based on the review of similar complaints and as per cp_sem_err_001, the error code 431 (rc_resolver_signal) can be due to: - pump resolver fixation loosened / resolver defective; - defective hms (motor control) board.Authorized technician inspected the unit and found that the roller pump motor controller board hms0409 (#90-305-770) was faulty and needed to be replaced.A device service history review has been performed and identified that the unit was manufactured in 2021 and no other similar event has been reported, neither concerning trend has been identified.Based on the outcome of service activity, the most likely root cause has been assigned to an electrical failure of the motor controller board.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro subcomponents.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 GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20023638
• Report Number: 9611109-2024-00374
• Device Sequence Number: 7335984
• Product Code: DTQ
• UDI-Device Identifier: 04033817900894
• UDI-Public: (01)04033817900894(11)210723
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• 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