MAUDE Adverse Event Report: LIVANOVA USA AOR ROOT CAN W/OUT VENT LN 12G; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	AR-11012
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the aoritc root cannula.The incident occurred in usa.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 receieved a report that during a procedure, the distal p plastic cap of the metal needle of the aorting cannula came off when inserted.This caused patient to have blood loss from aorta.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: no other similar events occurred for other units belonging to product lot of involved device, neither concerning trend was identified.Unit was requested for investigation.However, only the female connector which disconnected from the needle was sent from customer, not the entire part.Visual inspection on returned sub-component was performed, which highlighted dried blood in the junction of the hole and needle; therefore, solvent distribution could not be verified.No visible defects were confirmed on the connector.Based on the above and on previous investigation results of similar events, the most likely root cause was reconducted to an insufficient bonding between the luer lock and the needle, reasonably traced back to an operator error occurred during components assembly at manufacturing line.The personnel will be involved in a dedicated training meeting awaring of customer reported condition.The risk is in the acceptable region.Livanova will keep the post market surveillance.
Event or Problem Description
See initial report.

• Brand Name: AOR ROOT CAN W/OUT VENT LN 12G
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: 19212229
• Report Number: 1718850-2024-00028
• Device Sequence Number: 15179346
• Product Code: DWF
• UDI-Device Identifier: 00803622103001
• UDI-Public: (01)00803622103001(240)AR-11012(17)251031(10)2230500006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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 Expiration Date: 10/31/2025
• Device Model Number: AR-11012
• Device Lot Number: 2230500006
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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