MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CARDIOPLEGIA SOLUTION ADMINISTRATION ADAPTOR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	CA-80010
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova usa inc.Manufactures the cardioplegia solution administration adaptor.The incident occurred in park ridge, illinois.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 related to air being entrained every time that they switched from antegrade to retro or visa versa with a cardioplegia solution administration adaptor.The issue occurred during procedure.There was no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: according to follow up with the customer, it was confirmed the same issue has previously occurred ten (10) time on same catalog item and lot (ca-80010, lot: 2416300024).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
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 the above, the event has been reassessed as not reportable.

• Brand Name: CARDIOPLEGIA SOLUTION ADMINISTRATION ADAPTOR
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA USA INC; lindberghstrasse 25; munich CO 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20735001
• Report Number: 1718850-2024-00040
• Device Sequence Number: 8297774
• Product Code: DWF
• UDI-Device Identifier: 00803622103780
• UDI-Public: (01)00803622103780(240)CA-80010(17)270611(10)2416300024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993818
• 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,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-80010
• Device Lot Number: 2416300024
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 02/12/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/16/2024; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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