MAUDE Adverse Event Report: LIVANOVA USA INC. CARDIOPLEGIA CANNULA ADAPTERS; AORTIC ROOT CANNULA, AIR ASPIRATOR, PERFUSION ADAPTER, VESSEL CANNULA

Model Number	CA-40010
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova usa inc.Manufactures the cardioplegia cannula adapter.The incident occurred in (b)(6), pennsylvania.Through follow-up communication livanova the following additional information: the leak was from the inlet side of the 4-way hub; air leak into the device occurred in at least one instance and it was removed before it was transmitted to the patient.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 usa inc.Received a report that, during procedure, four (4) cardioplegia adapters was found to be leaking and also air leak into the device occurred in at least one instance.Leaking devices were discarded and replaced by the customer.There was no patient injury.
Additional Manufacturer Narrative
Units were discarded by the customer nor visual evidence of the issue was available for investigation.The leaking connection is bonded using uv-adhesive during the manufacturing process.From the review of the database, further events of leak have been registered on this product code.Based on the above, the most likely root cause of the reported event has been traced back to an operator error occurred during the bonding phase in manufacturing.The personnel will be involved in a dedicated training meeting awaring of customer's complaint.Based on the intended use and different configurations of use of cardioplegia adapters, air bubbles are expected to form in the lines in an amount that would not be critical for the patient since the risk that air goes into the systemic circulation is very low.Accordingly, instruction for use prescribes to check that cardioplegia delivery set must be ensured to be free of air prior to cardioplegia solution delivery.In conclusion, this issue is not critical in terms of air management and it is unlikely that air is infused to the patient.Based on this, the event is being reassessed as not reportable 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: CARDIOPLEGIA CANNULA ADAPTERS
• Common Device Name: AORTIC ROOT CANNULA, AIR ASPIRATOR, PERFUSION ADAPTER, VESSEL CANNULA
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich CO 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21169042
• Report Number: 1718850-2025-00001
• Device Sequence Number: 4276406
• Product Code: DWF
• UDI-Device Identifier: 00803622103728
• UDI-Public: (01)00803622103728(240)CA-40010(17)270430(10)2412100074
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/14/2025

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: CA-40010
• Device Lot Number: 2412100074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown