MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CP5 CONSOLE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	CP5 CONSOLE
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided h11 livanova deutschland manufactures the cp5 console, the event occurred in indianapolis, united states.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 the cp5 console screen showed that the roller pump was running clockwise but it was actually running counter clockwise.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: a livanova field service engineer (fse) was dispatched to the facility to investigate the device and could confirm the issue.Reportedly, the unit suddenly reset to the default settings and the direction of rotation changed accordingly.As troubleshooting, the e/p pack ups module was replaced.Functional verification tests were performed with positive results.Unit was returned to service.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
A review of the device¿s service history indicated that no previous events had been reported concerning this unit.No adverse trends associated with this type of failure mode has been detected.Based on the investigation findings, the event was attributed to an internal system configuration loss caused by a malfunction of the ups module.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: CP5 CONSOLE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 23556377
• Report Number: 9611109-2025-90528
• Device Sequence Number: 10107616
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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
• Device Model Number: CP5 CONSOLE
• Device Catalogue Number: 48-20-00
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 03/18/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/17/2025; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown