MAUDE Adverse Event Report: LIVANOVA USA INC CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS; CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE

Model Number	AR-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue occurred prior to 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 requested at livanova usa inc for investigation and not yet received.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, during priming, the luerlock connection has detached from the skewer.There is not report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
At the submission of the case, the customer has provided picture confirming the reported disconnection.A review of the dhr did not identify any deviation, non-conformity or material issue relevant to the reported failure.Root cause investigation results highlighted that the uv dispense and curing process, performed on 100% inspection by the assembler and aimed to ensure the cure, is variable and require a well-trained assembler.As a part of continuous improvement project, in (b)(6) 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.In addition, in order to ensure a more stable and precise process for dispensing uv adhesive and uv curing, an equipment has been modified to dispense a fixed amount of uv adhesive and modifying uv curing process.The validation of the equipment, which now includes an integrated semi-automatic dispenser and uv flood light system, has been completed on (b)(6) 2020.Field data monitoring is started and is planned to be completed by (b)(6) 2021.At the moment, all the complained devices were manufactured before the implementation of the new curing equipment.Based on livanova health hazard assessment, the overall risk is considered acceptable also after the implementation of the manufacturing personnel re-training in september.Nevertheless improvement action is now implemented and the field data monitoring is on going.Livanova will maintain monitoring the market.

• Brand Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Common Device Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10554121
• Report Number: 1718850-2020-00040
• Device Sequence Number: 14129415
• Product Code: DWF
• UDI-Device Identifier: 00803622103056
• UDI-Public: (01)00803622103056(240)230331(17)AR-11114(10)2006200073
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/03/2020

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: 03/31/2023
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11114
• Device Lot Number: 2006200073
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1