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

Model Number	SCPC LEVEL BUBBLE
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: livanova deutschland manufactures the scpc.The incident occurred in (b)(6).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 that a patient sensor of a scpc did not reading anything.No further information is available.It cannot be excluded that the affected sensor is a bubble one and that did not detect air bubble.The issue occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
Livanova was informed that the complained problem was related to a pressure sensor that was not reading and showing dashes.Based on the information the event is related to a pressure sensor the event has been reassessed as not reportable since it has unlikely possibility of causing any patient injury.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 intial report.

• Brand Name: PRESSURE CONTROL
• 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 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22050829
• Report Number: 9611109-2025-90129
• Device Sequence Number: 12981899
• Product Code: DTQ
• UDI-Device Identifier: 04033817901020
• UDI-Public: (01)04033817901020(11)160914
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: SCPC LEVEL BUBBLE
• Device Catalogue Number: 60-03-75
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2016
• 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