MAUDE Adverse Event Report: LIVANOVA USA, INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Catalog Number	SU-20602
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Additional device information: lot number: multiple issues and multiple lot numbers (1813400128 and 1813400138) were reported by the customer.It is unknown which lot number(s) were affected by the reported issue.Expiration date: may 31, 2021 for both reported lot numbers.Device manufacture date: 1813400128 - may 14, 2018; 1813400138 - may 14, 2018.During follow-up communication with the customer, livanova requested additional information regarding the identity of the foreign material.The customer did not provide additional information and stated that we would be able to inspect the cannula upon return to livanova.The device has been requested for return to livanova for further investigation.If any additional information relevant to the reported issue is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that multiple rigid tip suction wands were identified to have foreign bodies.It is unclear from the photographs and information provided if the foreign bodies were ink markings or particles, and whether they were inside or outside of the cannula tubing.This issue was discovered during incoming inspection at the distributor.There was no patient involvement.
Additional Manufacturer Narrative
The three complained cannula were returned to livanova usa and subjected to visual inspection.One cannula was found to have a hair in the sealed packaging.The other two cannula were found to have small movable particles onto the tubing.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The most probable root cause of the failure is inadequate cleaning during the assembly of this products.The operators involved in the assembly of this product were retrained to prevent further occurrence of this issue.Livanova usa will keep monitoring the marked for similar issue.

• Brand Name: STANDARD AND SMALL RIGID TIP SUCTION WANDS
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 8166705
• Report Number: 1718850-2018-00023
• Device Sequence Number: 19493159
• Product Code: DTS
• UDI-Device Identifier: 00803622105876
• UDI-Public: 00803622105876
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K982891
• 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): 03/27/2019

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 Catalogue Number: SU-20602
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1