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

Model Number	60-02-60Z
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of a centrifugal pump drive which restarted three times.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: the log files of the centrifugal pump drive were analysed.A watchdog reset and a timeout error were identified.In addition, log files of all pumps used during the same surgery were analysed, and watchdog resets were retrieved as well.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: through follow-up communications, it was learned that high-frequency devices are present and generally used by the hospital, however there was no evidence such type of equipment was used at the time of the event.Also, it was confirmed that the equipotential cable was used in accordance with the ifu.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: a device complaint history review was performed and identified no previous similar events reported since unit installation.No adverse trend has been identified for this failure mode.According to the livanova instructions for use, it is strongly recommended to check the operating theatre and the ambient of the operating theatre for emissions of high frequency emitting devices and to always have connected the potential equalization cable to earth.Based on the investigation findings, the root cause of the event has been attributed to an external interference from high frequency unknown device.Disturbances may occur on all the system devices as well as a few of them, depending on the location of the emitting source and the propagation pathway (air or cable).Moreover, electromagnetic propagation is affected by absorption and reflection from structures, object and people, therefore it is not possible to foresee which devices may be affected.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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): LIVANOA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23886736
• Report Number: 9611109-2025-90630
• Device Sequence Number: 21198353
• Product Code: DWA
• UDI-Device Identifier: 04033817902782
• UDI-Public: (01)04033817902782(11)221129
• Combination Product (Y/N): N
• 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
• 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
• Operator of Device: Health Professional
• Device Model Number: 60-02-60Z
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 03/20/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/04/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown