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

Catalog Number 044003901

Device Problem Disconnection (1171)

Patient Problem Death (1802)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not yet returned.

Event Description

Livanova usa has been informed that, during a bypass, the tubing connection on the oxygenator inlet completely disconnected.During follow up information, livanova usa has been informed the patient has died 2 days after the event.

Manufacturer Narrative

The complained tubing was returned to livanova for investigation.Inspection of the tubing found the connection to be conforming to livanova specifications: the tie was present and solvent appropriately applied.No evidence of any process deviation was found.Dhr verification did not reveal any relevant information possibly linked with the claimed defect.Frequency of this type of event is low (improbable).Livanova investigation did not identify any device related problem patient outcome was not associated to any device problem.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Type of Device: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): LIVANOVA USA, INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: alessandro melchiorre ; 14401 w 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8298028
• MDR Text Key: 134768778
• Report Number: 1718850-2019-00004
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622113338
• UDI-Public: (01)00803622113338(240)044003901(07)200930(10)1827000013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 044003901
• Device Lot Number: 1827000013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death