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

Model Number	10-88-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 mast roller pump.According to information, this is a critical error and pump stop event.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, during a procedure, the mast roller pump 150 displayed "shaft angle encoder fault" error.According to customer, the issue is temporary and arises intermittently, making it challenging to regulate the pump.There is no report of any patient injury.
Additional Manufacturer Narrative
As per follow up with the customer, the mast mount pump was previously used as an arterial pump.As a precaution, customer decided to use the suspected pump as an additional sucker.After making this change, customer did not encounter any shaft encoder error messages and customer could run the pump for the entire day without issues.Through consultation with livanova technical service, customer was suggested to replace the control panel by another one to check if this solves the issue and/or to replace the encoder in this panel to a new one.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.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
No component change was performed prior to returning the pump to service.Review of the complaints database revealed that no other similar occurrences were notified since unit installation in 2024, neither a concerning trend has been identified.Based on the above findings, considering that no part replacement was carried out and no further occurrence of the error was reported, it cannot be ruled out that the most likely root cause of the event was a temporary communication error between the hkr processor board and the shaft angle encoder.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20415953
• Report Number: 9611109-2024-00461
• Device Sequence Number: 8304023
• Product Code: DTQ
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)240223
• Combination Product (Y/N): N
• Initial Reporter Country: CE
• PMA/510(K) Number: K103762
• 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,Followup
• Report Date (Section B): 04/28/2025

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: 10-88-00
• Device Catalogue Number: MAST ROLLER PUMP 150
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 03/31/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/22/2024; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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