MAUDE Adverse Event Report: LIVANOVA USA INC TUBING, PUMP, CARDIOPULMONARY BYPASS22; COBE SMARXT TUBING AND CONNECTORS

Model Number	CONNECTOR
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa has received reports of y connectors presenting a film inside one of y limbs.The issue occurred at setup, prior to any patient involvement.
Additional Manufacturer Narrative
Livanova usa has received reports of wyes connectors presenting a film inside one of y limbs.Visual inspection of the interior of two returned wyes connectors found to have flash inside due to a molding partially occluding one branch of each connector.The exterior of both connectors did not show any damage or defects.Simulated high flow test performed with both returned connectors confirmed the flow through the occluded branches was restricted and turbulent.The occluding material did not detach.A review of the dhr did not identify any deviation relevant to the reported issue.No other similar complaint has been received for the claimed lot.The investigation confirmed the reported event: the wyes connectors were found to have flash due to molding.The health hazard evaluation assessed the residual risk resulted acceptable.This type of wye connectors is supplied to livanova by supplier.The supplier has been informed of the issue.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS22
• Common Device Name: COBE SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 9179546
• Report Number: 1718850-2019-00016
• Device Sequence Number: 2615587
• Product Code: DWF
• UDI-Device Identifier: 00803622123313
• UDI-Public: (01)00803622123313(240)050525000(17)220131(10)1900300179
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• 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): 04/21/2020

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: No Information
• Device Expiration Date: 01/31/2022
• Device Model Number: CONNECTOR
• Device Catalogue Number: 050525000
• Device Lot Number: 1900300179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1