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

Model Number	10-80-00Z
Medical Device Problem Code	Increased Pump Speed (1501)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
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 pro version.The incident occurred in (b)(6), italy.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 stating that a s5 roller pump showed the following abnormal behaviors frequently: it rotated faster on its own, it got stuck and it was not possible to rotate it manually either.The event occurred in-service.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
A livanova field service engineer was dispatched the customer, returned the pump to livanvoa and replaced it with a loaner.Initial investigation of the complained pump found no error message.The pump is mechanically tough.The possible explanation is that substance may have fallen on the pump which has oxidized everything and makes it difficult to turn the rotor.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H 11; device was returned to customer.Prior to test run of the device, the error could not be confirmed.Device has been cleaned, disinfected and visually checked, no issue identified.To solve the issue, the following parts has been replaced: clamp for tubing and s5 pump cover 150.Preventive maintenance completed and test run for 24 hrs performed and no issue observed: during complete procedure no error occurred - device works error-free.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
According to the complaints database review, no further issues have been submitted for this unit since its installation in 2021, neither a concerning trend has been detected.Based on the above facts and considering the results of device inspection, it cannot be ruled out that the most likely root cause of the reported case was a temporary failure of the pump, possibly linked to dirt and oxidation, that was fixed during the technical inspection of the unit.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 ROLLER PUMP PRO VERSION
• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19928507
• Report Number: 9611109-2024-00354
• Device Sequence Number: 8235026
• Product Code: DTQ
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)210520
• 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,Followup
• Report Date (Section B): 01/20/2025

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: 10-80-00Z
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 11/29/2024; 12/24/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/11/2024; 12/20/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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