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

Catalog Number	044003901
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): LIVANOVA USA, INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 8298028
• Report Number: 1718850-2019-00004
• Device Sequence Number: 1991290
• Product Code: DWE
• UDI-Device Identifier: 00803622113338
• UDI-Public: (01)00803622113338(240)044003901(07)200930(10)1827000013
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death