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

Catalog Number 627331801

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

A photograph provided by the customer confirmed the presence of a white particle in the line.The device has been requested for return to livanova for further evaluation.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 issue is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that a white particulate was identified in the capped blue blood line of the custom perfusion tubing set during setup.The user was able to move the particulate through manipulation of the tubing.There was no patient involvement.

Manufacturer Narrative

The two complained cardioplegia lines were returned to livanova usa for investigation.Visual inspection of the pack lines found white fibrous particles of similar material of fabric swabs used in the manufacturing process.The operators involved in the assembly of these packs will be retrained to prevent re-occurrences of this issue.As the frequency of this type of event is low (incredible, <1*10-6), no other action will be undertaken.Livanova will maintain monitoring the market for similar events.

• 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 ; 2812287575
• MDR Report Key: 8240359
• MDR Text Key: 132926543
• Report Number: 1718850-2019-00002
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622126475
• UDI-Public: (01)00803622126475(240)627331801(17)200930(10)1826000049
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 627331801
• Device Lot Number: 1826000049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2018
• 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