MAUDE Adverse Event Report: MUNICH SRD S5 CONSOLE FOR 4 PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	SRD S5 CONSOLE FOR 4 PUMP
Medical Device Problem Codes	Decreased Pump Speed (1500); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the cp5.Serial read out (real time device parameters and setting recording file) of the pump was collected a livanova field service engineer was dispatched the customer and could not reproduce the issue.At set 4.00 lpm, the actual read was 3.94 (at 1866rpm), after 30 minutes, flow reduced of by 0.04lpm.The rpm readout at 2000 rpm was confirmed to be 2000 rpm.The field tests were inconclusive and the cp5 appears to be working correctly.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 has received a report that, during the start of a case, the cp5 flow started dropping without input.They turned the cp5 up to max 3500 rpm and flow continued to drop below needed limits.They swapped pump out for rest of case.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: the complained cp5 unit was returned to livanova but was not repaired, as the device was more than 10 years old.A review of the device¿s service history confirmed that the system was manufactured in 2014 and that no previous reports of similar events had been communicated to livanova.Given that the issue could not be reproduced, it is reasonable to consider this a non-systematic event; based on findings from investigations of similar cases, the possibility of a problem along the tubing line (e.G., kinking) or a temporary failure of an internal component cannot be excluded.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: SRD S5 CONSOLE FOR 4 PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MUNICH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22662659
• Report Number: 9611109-2025-90276
• Device Sequence Number: 7495896
• Product Code: DTQ
• UDI-Device Identifier: 04033817902676
• UDI-Public: (01)04033817902676(11)220301
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: SRD S5 CONSOLE FOR 4 PUMP
• Device Catalogue Number: 48-40-00Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2022
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown