MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CP5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	DRIVE UNIT
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.- a.5.There was no patient involvement.H11: livanova deutschland manufactures the cp5 pump, the event occurred in the united states.Livanova field service engineer dispatched onsite confirmed the issue.The pump was not repaired since at end of life status and was removed from service.A review of the device service history confirmed that no similar events have been communicated to livanova since its manufacturing date (2007).A review of the complaints database did not identify any trends associated with this type of failure.Based on investigation findings, the most likely root cause of the event is associated with a defective cp5 drive unit or control panel, likely caused by progressive wear of the electromechanical device.This wear could have been initiated or accelerated by the specific use conditions at the customer's site, including situations that may be unintended, occasional, or not consistently repeated that can produce cumulative effects over time.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
Livanova deutschland received a report that the centrifugal pump cp5, used as arterial pump, provided unstable flow during procedure.There was no patient involvement.

• Brand Name: CP5
• Common Device Name: CONTROL, PUMP SPEED, 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
• MDR Report Key: 24573777
• Report Number: 9611109-2026-90083
• Device Sequence Number: 21430463
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)210825
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: DRIVE UNIT
• Device Catalogue Number: 60-01-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 08/25/2021
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown