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

Catalog Number	044040002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow-up communication with the customer, it was confirmed that there was no patient impact as a result of this event.The customer also stated that the livanova perfusion tubing set and the pump used during the procedure are not suspected to be the cause of the issue.No further information has been provided.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by customer.
Event or Problem Description
Livanova received a report that air was identified in the venous line of the perfusion tubing set during a procedure.The customer reported that the situation rapidly became unmanageable and intervention by several members of the surgical team was required to attempt to remove the air.The air could not be removed and the line was clamped and the bypass was stopped.Vacuum was added to the line to remove the air and the situation was not improving until blood suddenly began to fill the venous cannula and the air was able to be removed.Bypass and cross-clamp were removed and the bypass procedure was completed without any further issues.There was no report of patient injury.
Additional Manufacturer Narrative
No specific components of the perfusion tubing set were mentioned by the customer or otherwise implied to have contributed to the event.No photos of a potential defect were provided by the customer, and no product was returned to livanova in connection with this report.In addition, the customer has stated that they do not believe that the tubing set was the source or cause of the air in the line.No further investigation is possible at this time.No root cause or corrective actions were identified, as there was no information provided to conclusively suggest a failure occurred.
Additional Manufacturer Narrative
In the first follow-up report, submitted september 14, 2018, the "date of this report" field was erroneously entered as september 10, 2018.This should have been entered as the submission date; september 14, 2018.In the first follow-up report, submitted september 14, 2018, the "if follow-up, what type" field was erroneously left blank.This field should have been filled in as "additional information.".

• Brand Name: 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: 7649498
• Report Number: 1718850-2018-00010
• Device Sequence Number: 11318202
• Product Code: DWE
• UDI-Device Identifier: 00803622133688
• UDI-Public: (01)00803622133688(240)044040002(17)200331(10)1807800021
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2018

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: 03/21/2020
• Device Catalogue Number: 044040002
• Device Lot Number: 1807800021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 09/14/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 09/14/2018; 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1