MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH 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	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the cp5.According to follow up, the pump stopped and the alarm motor control (error 442) was displayed.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, just before the procedure started, the cp5 pump was stopped.This was used as a suction.The perfusionist was then able to quickly switch to another pump that was free.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.11 livanova field service engineer was dispatched at the customer facility, confirmed the issue and, to fix it, the motor control board has been replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11 the analysis of complaints database confirmed that no similar events have been reported in the past.Following investigation, the root cause of the reported malfunction was traced back to a defective motor controller board.Failures of electronic boards are known to arise from multiple, non-deterministic factors, including exposure to heat, dust, and moisture, accidental impacts such as drops or falls, power overloads or surges, and even variability within 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
See initial report.

• Brand Name: CP5
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22195034
• Report Number: 9611109-2025-90178
• Device Sequence Number: 15887605
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)160629
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K112225
• 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,Followup
• Report Date (Section B): 11/25/2025

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: CP5 CENTRIFUGAL PUMP
• Device Catalogue Number: 60-01-04
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 10/29/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 10/18/2025; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown