MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	AR-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
18 ar-11012 cannula were returned for investigation.Visual inspection of the 18 units found the bonding compound was present on one side of the cap and not uniform around the connection to the trocar needle as expected.A review of the dhr did not identify any deviation, non-conformity or material issue relevant to the reported failure.Livanova investigation clarified that the disconnection was ascribable to an operator error while distributing of adhesive between connector and trocar (needle).As a part of continuous improvement project, in september 2019 the standard operating procedure for the manufacturing of the complained cannula has been revised including additional check for first piece in curing trocar to luer bond and additional 100% inspection of adhesive cure for trocar to luer bond with needle to test for softness.Manufacturing personnel has been trained on the new revision of the procedure on (b)(6) 2019.Livanova is committed to identify possible corrective actions in the manufacturing process aimed to reduce/eliminate this potential human error.Livanova will keep monitoring the market for similar events.
Additional Manufacturer Narrative
The issue occurred at setup, prior to any patient involvement.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been received at livanova usa inc for investigation.Investigation is ongoing.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has been informed that the cap that help to extract the metal needle inside the aortic root cannula detaches from the metal needle.The issue occurred at setup, prior to any patient involvement.

• Brand Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 9201229
• Report Number: 1718850-2019-00017
• Device Sequence Number: 19609674
• Product Code: DWF
• UDI-Device Identifier: 00803622103001
• UDI-Public: (01)00803622103001(240)AR-11012(17)220228(10)1903500101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972503
• 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): 11/15/2019

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: 02/28/2022
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11012
• Device Lot Number: 1903500101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1