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

Model Number RA-XXXXX

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2020

Event Type  malfunction  

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 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.

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 Description

See initial report.

• Brand Name: AORTIC ARCH CANNULAS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11169030
• MDR Text Key: 227944702
• Report Number: 1718850-2021-00021
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622105050
• UDI-Public: (01)00803622105050(240)RA-1138(17)220930(10)1925200115
• Combination Product (y/n): N
• PMA/PMN Number: K943934
• 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: 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
• Device Operator: 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 Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1