MAUDE Adverse Event Report: LIVANOVA USA CARDIOPLEGIA ADAP STR 14 CM; CATETHER

Model Number	CA-10010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa received a report that, during during a pre-test, a lack of sealing in two (2) the cardioplegia adapter connectors occurred.The connector is use to connect the needle with the aortic aspiration and ensure deering.A 3rd connector was connected and it correctly worked.There is no report of any patient injury.As per patient report:lot: adatt emost_adattatore cardiopl dir 14cm_ca-10010_calmed laboratories 2401600006 expiry: 15/01/2027.Specifically, it is reported that during a pre-test, a lack of sealing of the connector occurred.The device is used to connect the needle with the aortic aspiration and ensure deering.During a test before connecting the needle to the aorta to check the system, it was noted that the adapter was not sealed.Subsequently, the test was repeated with another adapter and the system worked, confirming that the problem was the adapter and not the aspirator.
Additional Manufacturer Narrative
A.1.-a.5.No patient information has been provided.H.11.Livanova manufactures the straight adapter.The involved device has been requested for investigation.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
H11: following analysis completion of the issue occurred, it was concluded that reportability of the event changes from reportable to not reportable due to the following rationale.Based on the intended use and different configurations of use of cardioplegia adapters like this one, 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, device instructions 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 being infused to the patient.Through follow-up communication with the customer, it was confirmed a lack of sealing of the adapter.Units were requested but did not return for investigation.Complained adapter is assembled by bonding male luer connector to tubing at the proximal end and connector with vent at the distal end (i.E.At the tip).Both connections are bonded using uv-adhesive in the manufacturing.From the review of the database, no further similar events have been registered on this lot out of 100 manufactured units, nor 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.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.

• Brand Name: CARDIOPLEGIA ADAP STR 14 CM
• Common Device Name: CATETHER
• Manufacturer (Section D): LIVANOVA USA; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20351389
• Report Number: 1718850-2024-00039
• Device Sequence Number: 8024181
• Product Code: DWF
• UDI-Device Identifier: 00803622103605
• UDI-Public: (01)00803622103605(17)270115(10)2401600006(11)240129(240)CA-10010
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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-10010
• Device Lot Number: 2401600006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown