MAUDE Adverse Event Report: LIVANOVA USA INC AORTIC ARCH CANNULAS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	RA-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred prior to any patient involvement.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Clarification on the unit availability has been requested.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 received a report that, at the unpacking of the device, the tip of the aortic cannula was found disconnected from the body of the cannula.The event occurred prior to any patient involvement.
Additional Manufacturer Narrative
Livanova received a report stating that, during unpacking, the tip of the aortic cannula was found disconnected.There was no patient/user involvement.Investigation was based on pictures provided by the customer at the submission of the case.The dhr review of the complained lot confirmed the device was released according to product specifications.Based on livanova complaint database review, there is one similar event of tip disconnection related to the same device lot.No other event relevant to the same item code in the last 12 months.Based on livanova investigation, the most probable root cause is insufficient application of the uv adhesive during the manual assembly of the device.To prevent reoccurrence, on 23 november 2020, the personnel involved in the manufacturing of this type of devices was involved in a dedicated training.The risk is acceptable.No other corrective action will be undertaken.Livanova will keep monitoring the market.Investigation based on picture.
Event or Problem Description
See initial report.

• Brand Name: AORTIC ARCH CANNULAS
• 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: 11169030
• Report Number: 1718850-2021-00021
• Device Sequence Number: 2551124
• Product Code: DWF
• UDI-Device Identifier: 00803622105050
• UDI-Public: (01)00803622105050(240)RA-1138(17)220930(10)1925200115
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K943934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• 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): 03/05/2021

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: 09/30/2022
• Device Model Number: RA-XXXXX
• Device Catalogue Number: RA-1138
• Device Lot Number: 1925200115
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1