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

Catalog Number	044035103
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.A photograph was received confirming the reported issue.Livanova was made aware that the metal shard is available 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.Device not yet returned.
Event or Problem Description
Livanova received a report that a metal shard was observed exiting the stainless steel cooling coil of the custom perfusion tubing set during priming.The metal shard was not able to be located after initial observation and the pack was changed out for the procedure.There was no patient involvement.
Additional Manufacturer Narrative
The stainless steel cooling coil and attached lines were returned to livanova for evaluation.During visual inspection, a metal shard was found lodged in the reverse drip chamber on the outlet line downstream from the stainless steel coil, confirming the issue.This coil is provided to livanova by a supplier.A supplier quality notification has been initiated to address this quality concern with the supplier.Further corrective action will be enacted through the sqn process.The root cause of the failure was determined to be a failure in the manufacturing process of the stainless steel coil.
Additional Manufacturer Narrative
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
• Common Device Name: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 7735139
• Report Number: 1718850-2018-00013
• Device Sequence Number: 13683207
• Product Code: DWE
• UDI-Device Identifier: 00803622135187
• UDI-Public: (01)00803622135187(240)044035103(17)200531(10)1815100034
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2018

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: 05/31/2020
• Device Catalogue Number: 044035103
• Device Lot Number: 1815100034
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 09/27/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 09/07/2018; 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1