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

Catalog Number	046006400
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.It is unknown at this time if the event was related to an issue with the disposable or the equipment.A (b)(4) field service representative was dispatched to the facility to inspect the equipment and the issue could not be duplicated.At this time, it is unknown if the disposable product will be made available for return to (b)(4).If any additional information relevant to the reported issue is received, it will be provided in a supplemental report.Product availability is unknown.
Event or Problem Description
(b)(4) received a report that flow was lost during a procedure and air appeared in the arterial line of the custom perfusion tubing set, indicating retrograde flow.The user was able to regain forward flow and the case was continued.There was no report of patient injury.
Additional Manufacturer Narrative
Through follow-up communication with the customer, livanova usa learned that the product was discarded by the facility risk management department after it was confirmed that there was no adverse affect on the patient.It is still unknown at this time if the disposable product experienced a malfunction.As the customer has discarded the device and closed the investigation on their end, no further investigation can be performed and a root cause could not be determined.Device discarded by customer.

• 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: 7137496
• Report Number: 1718850-2017-00020
• Device Sequence Number: 16411282
• Product Code: DWE
• UDI-Device Identifier: 00803622133954
• UDI-Public: (01)00803622133954(240)046006400(17)190930(10)1726300068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/09/2018

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: 09/30/2019
• Device Catalogue Number: 046006400
• Device Lot Number: 1726300068
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1