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

Catalog Number	627298302
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
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 available.
Event or Problem 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.
Additional 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
• Common Device Name: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): LIVANOVA USA, INC; 14401 w 65th way; arvada 80004
• MDR Report Key: 8281013
• Report Number: 1718850-2019-00003
• Device Sequence Number: 19430507
• Product Code: DWE
• UDI-Device Identifier: 00803622125980
• UDI-Public: (01)00803622125980(240)627298302(17)191231(10)1734800069
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 627298302
• Device Lot Number: 1734800069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/28/2019
• 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