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

Catalog Number	627362301
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id was not provided.Patient birth date was not provided.Patient weight was not provided.Patient death date was not disclosed.Livanova has been informed the event occurred on (b)(6) 2017.Event date was not disclosed.Livanova has been informed the event occurred on (b)(6) 2017.(b)(6).Several attempts have been made to gather additional information about the event from the customer.However, no additional information has been provided at this time.It is unknown how the patient died, how and if the product was involved.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available.
Event or Problem Description
Livanova usa inc has received via the u.S.Mail the medwatch report # (b)(4) stating that, during a procedure, while applying the stopcock/luer lock of the inlet line of the right ventricular assist device (rvad) to inflow cannula, there was an audible cracking sound and air was being entrained.The patient died.
Additional Manufacturer Narrative
Nor the claimed device neither picture were provided for evaluation to livanova usa inc.According to information, the event occurred more than a year before the date livanova usa has been informed.Attempts were done to clarify the sequence of events but customer could not provide any additional explanation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova is not aware of any other similar complaint related to product code.Available information did not point out any device malfunction.Livanova will keep monitoring the market for similar events.

• 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: 8358210
• Report Number: 1718850-2019-00006
• Device Sequence Number: 2285288
• Product Code: DWE
• UDI-Device Identifier: 00803622132759
• UDI-Public: (01)00803622132759(240)627362301(179190630(10)1717700066
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/17/2019

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: 06/30/2019
• Device Catalogue Number: 627362301
• Device Lot Number: 1717700066
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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
• Patient Age: 70 YR