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

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2020

Event Type  malfunction  

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 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 Description

See initial report.

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
• Type of Device: 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
• MDR Text Key: 207550193
• Report Number: 1718850-2020-00040
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622103056
• UDI-Public: (01)00803622103056(240)230331(17)AR-11114(10)2006200073
• Combination Product (y/n): N
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1