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

Catalog Number	627331801
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photograph provided by the customer confirmed the presence of a white particle in the line.The device has been requested for return to livanova for further evaluation.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 issue is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that a white particulate was identified in the capped blue blood line of the custom perfusion tubing set during setup.The user was able to move the particulate through manipulation of the tubing.There was no patient involvement.
Additional Manufacturer Narrative
The two complained cardioplegia lines were returned to livanova usa for investigation.Visual inspection of the pack lines found white fibrous particles of similar material of fabric swabs used in the manufacturing process.The operators involved in the assembly of these packs will be retrained to prevent re-occurrences of this issue.As the frequency of this type of event is low (incredible, <1*10-6), no other action will be undertaken.Livanova will maintain monitoring the market for similar events.

• 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: 8240375
• Report Number: 1718850-2019-00001
• Device Sequence Number: 2189621
• Product Code: DWE
• UDI-Device Identifier: 00803622126475
• UDI-Public: (01)00803622126475(240)627331801(17)200731(10)1821200057
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 04/26/2019

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: 627331801
• Device Lot Number: 1821200057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1