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

Catalog Number	200-200
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6910181
• Report Number: 1718850-2017-00016
• Device Sequence Number: 18953185
• Product Code: DWF
• UDI-Device Identifier: 00803622125812
• UDI-Public: 00803622125812
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 200-200
• Device Lot Number: 181185
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0076-2018
• Patient Sequence Number: 1