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

Model Number	CP5 CENTRIFUGAL PUMP
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5: patient information was not provided.H11: livanova field service engineer was dispatched on site and confirmed the reported condition.The motor control board was replaced.After performing all the functional tests with positive results, the unit was released back into regular service.The involved cp5 was manufactured in 2016 and complaints database review revealed that no other similar event has been reported to livanova.No adverse trend was detected concerning this failure mode.Based on the investigation findings, the root cause of the reported event has been traced back to a faulty motor control board.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro subcomponents.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 received a report about a cp5 system displaying the error message "motor control failure".The event occurred during priming.There is no report of any patient injury.

• 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 80004
• MDR Report Key: 24911192
• Report Number: 9611109-2026-90158
• Device Sequence Number: 21288971
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)160125
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/17/2026

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: CP5 CENTRIFUGAL PUMP
• Device Catalogue Number: 60-01-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 01/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown