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

Model Number	10-80-00Z
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
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 (b)(6).During maintenance activity performed by a livanova field service representative, the involved pump was tested at different speed in its entire range and it was possible to hear the noise at all of them.In addition, difficulties to rotate smoothly and resistance when operate manually were detected on the pump.Device seems to not work properly.Livanova initiated an investigation.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 received a report that a s5 roller pump 150 had some difficulties to rotate smoothly and with no noise.Some resistance/friction was also present when trying to operate the pump manually.The issue occurred during maintenance activity.There was no patient involvement.
Additional Manufacturer Narrative
H 11: a device service history review has been performed and identified that the unit was manufactured in 2022 and no other similar event has been reported, neither concerning trend has been identified.The issue was initially detected at tssi during repair activity.The most likely root cause of the reported event is a defective pump head, likely due to bearing's deterioration.The wearing of electro-mechanical devices can be originated by the specific use condition at customer site that may have contributed to the event, such as movements or liquids penetration.However, there is no concerning trend for this kind of failure.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.
Additional Manufacturer Narrative
The complained s5 roller 150 was inspected, and the error could not be confirmed.A run test has been performed for some hours and no errors associated to the display or interruption of the pump have been detected.Some resistance/friction is also present when trying to operate the pump manually.To solve this problem, the s5 pump panel, the s5 pump head and basement pumping house rp150 was performed.Device was tested and no other issue was identified.Device was released for use.Based on all the above, the most likely root cause previously identified (defective pump head, likely due to bearing's deterioration) is confirmed.
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 GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20178090
• Report Number: 9611109-2024-00405
• Device Sequence Number: 18217238
• Product Code: DTQ
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)221214
• 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,Followup
• Report Date (Section B): 06/12/2025

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: 10-80-00Z
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 11/29/2024; 05/12/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 12/12/2024; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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