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

Model Number	PUMP CONTROL PANEL
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report of a control panel of the centrifugal pump which shut down during procedure.Reportedly, the centrifugal pump stopped rotating.After 8 seconds, the panel automatically turned back on without external interference, and the pump remained at 0 rounds per minute.The operating room staff began increasing the rotations using the potentiometer until they reached the required number of revolutions to ensure the patient's blood flow in the operating room.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: a livanova field service engineer (fse) was dispatched to the facility for investigation.The control panel log files were retrieved and analysed.An error message into the log was present, "index impulse missing", indicating that the received signal for speed from hall sensor is faulty, ferrites were then applied to all centrifugal pump cables and pumps.The control panel switch was replaced.All tests conducted onto involved unit passed without further issue.Through follow-up communication, livanova learned that an external device monitor connected to the hart-lung machine shut down during the failure of the control panel.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: complaints database review revealed no further similar events since unit¿s installation.No concerning trend was highlighted for reported failure mode.Based on investigation findings, considering that no hardware malfunction of the pump was found, the reported event was most likely due to an external interference from high frequency unknown device.As per product instructions for use, the connection cable of the cp5, the drive unit and the flow sensor cable must be fitted with the appropriate blocking ferrites.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 DRIVE UNIT
• 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: 23325841
• Report Number: 9611109-2025-90452
• Device Sequence Number: 10637558
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)160210
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: PUMP CONTROL PANEL
• Device Catalogue Number: 60-02-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown