MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ CENTRIFUGAL PUMP DRIVE UNIT; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	CPD
Medical Device Problem Code	Increased Pump Speed (1501)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that the centrifuge pump used on essenz heart lung machine (hlm) started on its own, during priming.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz centrifugal pump drive unit.The incident occurred in zurich, switzerland.Through follow-up communication livanova learned the following additional information: the centrifugal pump started automatically on its own and no error message was displayed.In addition, it was reported formation of mixture of air and liquid.Further clarification is ongoing.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 the log files revealed no technical error message displayed onto the unit.No technical error referring to a deviation of the centrifugal pump drive was stored.Complaint database review revealed no further similar events since unit's manufacturing date for involved device, and no other occurrences of the reported failure mode were reported.The event could be considered an isolated event.Based on investigation findings, a hardware malfunction of the centrifugal pump could be ruled out, and the root cause of the reported issue could not be determined.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: ESSENZ CENTRIFUGAL PUMP DRIVE UNIT
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, 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: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22978840
• Report Number: 9611109-2025-90343
• Device Sequence Number: 21189679
• Product Code: DTQ
• UDI-Device Identifier: 04033817903031
• UDI-Public: (01)04033817903031(11)231128
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K232291
• 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): 12/10/2025

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: CPD
• Device Catalogue Number: 60-04-50
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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