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

Model Number	EC2140S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Livanova usa inc manufactures the connector.The incident occurred in (b)(6).The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.Investigation of previous similar event confirmed the internal lumen of the 1/4 x 3/8 connector was partially occluded by a plastic film.Possible root cause that cannot be excluded is 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.
Event or Problem Description
Livanova inc has received a report that a 1/4 x 3/8 connector had a reduction on tube size due to piece of plastic causing blood flow reduction while trying to perfuse on pump.The customer was not sure if plastic was loose.There is no report of any patient injury.

• Brand Name: 1/4 X 3/8 REDUCER
• Common Device Name: CONNECTOR
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11853866
• Report Number: 1718850-2021-00029
• Device Sequence Number: 4420656
• 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): 05/20/2021

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: EC2140S
• Device Lot Number: 2023800120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• 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