MAUDE Adverse Event Report: LIVANOVA USA FLEX FLOW VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 200-200

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The exact device manufacture date is unknown, as this product was not manufactured by livanova usa.This information will be provided in a supplemental report if received.The involved product has been requested for return to livanova usa.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova received a report that the tips of several flex flow venous cannulae were found to be sharp/pointed when they should be blunt.This issue was noted during setup and the product was not used.There was no patient involvement.

Manufacturer Narrative

In the initial report, submitted october 3, 2017, the device code was inadvertently left blank.The code should have been selected as "(b)(4) - device issue." eight flex flow venous cannula were returned for examination.Visual inspection confirmed that the obturator for all eight cannula was pointed instead of blunt.An outside supplier provides the obturators to livanova for use with the reported catalog number.A review of the design confirmed the tip shape is called out and should be "blunt with a round, closed end." the affected lot number was isolated and the supplier was notified through a supplier quality notification.Further communication with the supplier revealed that a new tool had been developed for the production of this component, which created a sharp/pointed tip.The affected lot number was manufactured using obturators with pointed/sharp tips.The total lot build was for 1000 units.A field action (b)(4) was initiated for all product already distributed.Product not yet distributed was placed on quality hold and will not be distributed further.A capa has been initiated to further investigate this type of issue and to implement any necessary corrective actions.

• Brand Name: FLEX FLOW VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6910181
• MDR Text Key: 88163284
• Report Number: 1718850-2017-00016
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622125812
• UDI-Public: 00803622125812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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: 07/31/2020
• Device Catalogue Number: 200-200
• Device Lot Number: 181185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-0076-2018
• Patient Sequence Number: 1