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

Catalog Number	044035103
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved cardioplegia line was returned to livanova for further investigation.Plugs were present at all line ends to retain fluid still in the lines.Visual inspection confirmed that debris was present in the line.The debris, which appears to be metal with jagged edges and curled ends, was found floating in the bubble trap.All other remaining components were inspected and no additional debris was found.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 event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that a metal shaving was observed in the post-heat-exchanger-coil cardioplegia tubing of the custom perfusion tubing set.This was discovered during a procedure.The shaving made its way to the rdc and stayed there.The customer opened a new pack and set up a new cardioplegia circuit to continue the procedure.There was no report of patient injury.
Additional 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
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 7698169
• Report Number: 1718850-2018-00012
• Device Sequence Number: 1753808
• Product Code: DWE
• UDI-Device Identifier: 00803622135187
• UDI-Public: (01)00803622135187(240)044035103(17)200531(10)1814300030
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 1814300030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1