MAUDE Adverse Event Report: LIVANOVA USA, INC CARDIOPLEGIA ADAPTER CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	CA-XXXXX
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova usa inc.Manufacture the cardioplegia adapter cannula.The event occured in (b)(6).If any additional information pertinent to the reported issue is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc.Received a report that during cardioplegia administration a leak of fluid appeared at the y connector of the cardioplegia adaptor.It was reported risk of air delivery to the patient.There was no report of patient injury.
Additional Manufacturer Narrative
Visual inspection of the two returned ca-20070 cannula devices found a void path in the connection between the central connector and one of the two tubing branches.The returned cannula devices were subjected to leak test and the test reproduced the claimed leak.Investigation of the devices suggested the leak was caused by incorrect distribution of bonding solvent between the tubing and central connector.A review of the dhr did not identify any deviations or non-conformity relevant to the reported issue.The operators involved in the manufacture of these devices will be retrained to prevent further reoccurrence.In addition, livanova has issued a capa project (capa-arv-2017-0006) to further investigate the root cause for leakages associated to this type of cannula devices and identify adequate corrective actions.Livanova will keep monitoring the market for similar events.

• Brand Name: CARDIOPLEGIA ADAPTER CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 8311195
• Report Number: 1718850-2019-00005
• Device Sequence Number: 16564786
• Product Code: DWF
• UDI-Device Identifier: 00803622103681
• UDI-Public: (01)00803622103681(240)CA-20070(17)201031(10)1728200097
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 10/31/2020
• Device Model Number: CA-XXXXX
• Device Catalogue Number: CA-20070
• Device Lot Number: 1728200097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 04/27/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1