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

Catalog Number 627298302

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

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 available.

Event Description

Livanova usa inc received a report that after coming off bypass at the end of a case, during the night, the tubing that hooks up to the reservoir slipped off the terumo reservoir outlet and spilled fluid everywhere.There is no report of any patient injury.

Manufacturer Narrative

Nor the complained tubing neither picture of the event was provided for investigation.A dimensional analysis performed on tubing of the same lot of the complained one confirmed the tubing was released in compliance with product specifications.No additional dimensional analysis could be performed the claimed connection was made to a non-livanova component.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the unit was not available for investigation, no specific root cause of the issue could be identified.It cannot be excluded that the detachment of the tubing was triggered by rough handling of the device.Livanova usa will keep monitoring the market.Device not available.

• 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 80004
• Manufacturer (Section G): LIVANOVA USA, INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: njemile crawley ; 14401 w 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8281013
• MDR Text Key: 136187340
• Report Number: 1718850-2019-00003
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622125980
• UDI-Public: (01)00803622125980(240)627298302(17)191231(10)1734800069
• 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: 03/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 627298302
• Device Lot Number: 1734800069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2017
• 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