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

Catalog Number 044035103

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Photographs were received confirming the reported issue.Livanova was made aware that the metal shard is available for return and it has been requested.However, the device has not yet been returned.A supplier quality notification has been issued to the original manufacturer of the stainless steel coil to further investigate this type of issue.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.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 a metal shard was observed coming out of the metal coil of the custom perfusion tubing set during priming.There was no patient involvement.

Manufacturer Narrative

This coil is supplied to livanova by an outside supplier.A supplier quality notification was initiated to investigate this issue.Investigation connected with this event verified that, while the metal flake was determined to have come out of the coil during the procedure, it did not originate from the coil itself and is believed to have been deposited during one of the manufacturing processes.The root cause of this failure has been determined to be due to a defect in the supplier's manufacturing process.Livanova has implemented a change order to run air through all coils received to ensure that they are free of any debris prior to consumption into a perfusion pack.Additionally, livanova has initiated a capa to investigate this issue further.

• 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: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7735142
• MDR Text Key: 115587968
• Report Number: 1718850-2018-00014
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622135187
• UDI-Public: (01)00803622135187(240)044035103(17)200531(10)1814300030
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• 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: 044035103
• Device Lot Number: 1814300030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• 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