MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SCPC; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	ASY CENTRIFUGAL PUMP CONSOLE
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient informations were not provided.H.11 livanova manufactures the scpc, the incident occurred in germany.Livanova initiated an investigation.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 of an scpc console not properly functioning during procedure.Reportedly, the issue could be addressed to a battery problem.There was no report of any patient injury.
Additional Manufacturer Narrative
H11: livanova field service engineer dispatched to customer facility could not confirm the issue.Based on the available information and the activities performed, it is reasonable to conclude that the reported issue was likely associated with batteries intermittently failing to provide sufficient power to maintain system operation when disconnected from the mains.The simultaneous occurrence of a mains power failure and a battery malfunction is considered unlikely to occur.Following this information, the event has been re-assessed as non-reportable.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: SCPC
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, 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: annarita di lascio ; 14401 w. 65th way
• MDR Report Key: 23325564
• Report Number: 9611109-2025-90446
• Device Sequence Number: 10612818
• Product Code: DTQ
• UDI-Device Identifier: 04033817901013
• UDI-Public: (01)04033817901013(11)200320
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K020571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: ASY CENTRIFUGAL PUMP CONSOLE
• Device Catalogue Number: 60-03-00
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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