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

Catalog Number	627179903
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.A photograph was provided by the customer for review.However, it did not clearly show the reported issue.Clarification on the issue was requested and no confirmation could be provided.Inventory for this pack lot number was researched and there were no packs remaining for evaluation.The livanova sales representative indicated that the customer was able to modify the line without issue, and that they had additional product they were willing to use.The print drawing for this catalog number was inspected and it clearly shows the proper positioning of the filter and filter loop within the line.Although the reported issue could not be confirmed, this event was treated as a manufacturing error.The individual responsible for assembling this part of the pack was identified based on the reported lot number and remedial training was performed to ensure that the proper steps needed for this build were clearly understood.Through additional follow-up communication, livanova learned that the customer has not observed this issue in any other packs in the reported lot, and that it appears to be a one-time occurrence at this time.Device not returned.
Event or Problem Description
Livanova received a report that the arterial filter in a custom perfusion tubing set was found to be backwards during setup.There was no patient involvement.

• 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: 6987301
• Report Number: 1718850-2017-00018
• Device Sequence Number: 518869
• Product Code: DWE
• UDI-Device Identifier: 00803622108105
• UDI-Public: 00803622108105
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/27/2017

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: 06/30/2018
• Device Catalogue Number: 627179903
• Device Lot Number: 1721900053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1