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

Catalog Number 046000900

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2018

Event Type  malfunction  

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 Description

Livanova received a report that black marks were identified inside the pump head tubing of multiple custom perfusion tubing sets during setup.There was no patient involvement.

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
• Type of Device: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: njemile crawley ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 8166721
• MDR Text Key: 130621477
• Report Number: 1718850-2018-00026
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622124853
• UDI-Public: (01)00803622124853(240)046000900(17)200531(10)1814200112
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 046000900
• Device Lot Number: 1814200112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1