MAUDE Adverse Event Report: LIVANOVA USA INC 1/4 X 3/8 CONNECTOR

Model Number	Connector
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova usa inc manufactures the connector.The incident occurred in (b)(6) united states.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.The connector was returned to livanova for investigation.Visual inspection confirmed the internal lumen of the 1/4 x 3/8 connector was partially occluded by a plastic film.Possible root cause which cannot be excluded is due to a molding defect.The 1/4 x 3/8 connector is manufactured by a livanova supplier.The supplier has been formally informed of the event and requested to investigate the possible root causes.The risk is acceptable.No other action is deemed necessary.On 20 april 2021, livanova received a report of a second event relevant to same item device (livanova ref (b)(4)).Information received on the second event triggered the re-evaluation of the present case.
Event or Problem Description
Livanova inc has received a report that a 1/4 x 3/8 connector assembled in the bypass circuit to sell saver had a manufacturing defect inside the connector.The issue was obstructing flow and causing high pressure in the arterial bypass line.There is no report of any patient injury.

• Brand Name: 1/4 X 3/8 CONNECTOR
• Common Device Name: CONNECTOR
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11853867
• Report Number: 1718850-2021-00030
• Device Sequence Number: 3425288
• Product Code: DTL
• UDI-Device Identifier: 00803622129315
• UDI-Public: (01)00803622129315(240)EC2140S(17)230831(10)2023800120
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/19/2021

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: 08/31/2023
• Device Model Number: Connector
• Device Catalogue Number: EC2140S
• Device Lot Number: 2023800120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1