MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-80-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the s5 roller pump 150.Serial read out (real time device parameters and setting recording file) of the pump were provided and are being investigated.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received report that, the roller pump 150 alarmed for motor controller failure (431) pump 1 during a procedure.The pump could not be resumed though restart.There is no report of any patient injury.The pump is back to expected functions after power on the day after the event.
Additional Manufacturer Narrative
Technician on site inspected the unit and could not reproduce any fault.Device was returned to service after functional checks passed positively.No further issues has been reported by customer since technician inspection.A device service history review has been performed and identified that the unit was manufactured in 2017 and no other similar event has been reported, neither concerning trend has been identified.Pump read-out (real-time device parameters and setting recording file) were gathered and analyzed.Several errors on date of event such meaning resolver fixation loosened, defect in the connector, hms and motor have been disconnected due to a failure and pump run too fast were found.Taking into account all the above and the fact that pump restarted working properly on the day after the event, it cannot be ruled out that the most likely root cause of the reported event was a temporary electrical failure on the hms board as a false contact or bad connections which was definitively fixed by service technician throughout the equipment check.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: S5 ROLLER PUMP 150
• 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 80004 ; GM 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20830138
• Report Number: 9611109-2024-00579
• Device Sequence Number: 8584996
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)171023
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 10-80-00
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown