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

Catalog Number	AR-11112
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested but not yet 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.Device not yet returned.
Event or Problem Description
Livanova usa inc has been informed that, during a procedure, the luerlock connection has detached from the skewer during the application.There is not report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Ar-11112 units belonging to the complained lot were returned from the customer to livanova for investigation.The returned cannula was inspected, and the luer connector that is intended to be attached to the end of the needle, was found to not be adhered and was loose in the return bag.The separated luer connector was found to have sufficient uv bonding compound on the bottom of the connector.The needle was placed in the luer connector and found the needle fit loosely in the luer suggesting the bonding compound applied to this connection was not sufficient.A review of the dhr did not identify any deviation, non-conformity or material issue relevant to the reported failure.Livanova investigation confirmed the reported disconnection on returned devices.Livanova believes the disconnection was ascribable to an operator error while distributing of adhesive between connector and needle.A dedicated session of training has been performed with the manufacturing operators involved in the production of cannulae aortic root cannula.This type of failure has a low probability to cause a risk for the surgeon while removing detached guidewire cause.The failure it is not likely causing any serious injury to patient if it were to reoccur.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 september 17th, 2019.Livanova is committed to identify possible corrective actions in the manufacturing process aimed to reduce/eliminate this potential human error.Livanova will maintain monitoring the market.

• Brand Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 9303545
• Report Number: 1718850-2019-00022
• Device Sequence Number: 1864670
• Product Code: DWF
• UDI-Device Identifier: 10803622103046
• UDI-Public: (01)10803622103046(240)AR-11112(17)220331(10)1907100078
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/11/2019

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: 03/31/2022
• Device Catalogue Number: AR-11112
• Device Lot Number: 1907100078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1