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

Model Number	RP 150
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 roller pump 150 gave a motor controller error message (error code 432) and a whistle was heard by the user coming from the pump module.By turning off the module and turning it back on the error remained.The issue occurred post-procedure.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the s5 roller pump 150.The incident occurred in teramo, italy.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Motor control board (hms) and motor power amplifier board (hmf) were found with visibly blown components.Therefore, in order to solve the issue, they were 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
Field service technician went on site and provided the log files, which however were missing the error section (defect/fail/stop) and did not record anomalies on 25.10.2024.The review of machine service history revealed that it was installed in 2022 and no previous events were reported before.Based on the above, the most likely root cause of the issue is related to failure of the motor control boards.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impact (drops and falls), and power overloads/surges but also to variability of micro subcomponents.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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20756856
• Report Number: 9611109-2024-00562
• Device Sequence Number: 8422111
• Product Code: DTQ
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)220816
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210130
• 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
• Report Date (Section B): 02/19/2025

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: RP 150
• Device Catalogue Number: 10-80-00Z
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 01/26/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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