MAUDE Adverse Event Report: LIVANOVA USA, INC. CUSTOM PERFUSION TUBING SET; CARDIOPULMONARY BYPASS CUSTOM TUBING KIT

Catalog Number	046000900
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.(b)(6).Photographs were provided by the customer confirming the reported issue.At this time, the identity of the black mark/substance is unknown.The device has been requested for return to livanova for further investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that a black mark was identified inside the pump head tubing of the custom perfusion tubing set during setup.There was no patient involvement.
Additional Manufacturer Narrative
The complained cannula was returned to livanova usa.The customer has provided picture showing the presence of a black spot in the complained cannula.The problem was confirmed based on this evidence and inspection of the complained cannula.Inspection revealed the black spot presented a reddish ring suggesting its ink nature.A review of the dhr did not identify any deviation or non-conformity relevant to the reported issue.Based on similarity with previously investigated similar cases, the most probable root cause of the problem was ineffective cleaning of the extrusion line from previous colored plastic pellets.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.The manufacturing floor has been made aware of the event and specific retraining of the personnel done.Livanova will keep monitoring the market.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Common Device Name: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 8166717
• Report Number: 1718850-2018-00025
• Device Sequence Number: 1997818
• Product Code: DWE
• UDI-Device Identifier: 00803622124853
• UDI-Public: (01)00803622124853(240)046000900(17)200531(10)1814200112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/29/2019

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: 05/31/2020
• Device Catalogue Number: 046000900
• Device Lot Number: 1814200112
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1