MAUDE Adverse Event Report: LIVANOVA USA INC SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number	044027000
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was identified prior to any patient involvement.Livanova usa inc manufactures the convenience pack ut adv hrt (b)(6).The incident occurred in (b)(6) united states.The involved device has been requested for investigation.However, photographic evidences showing the reported issue were provided by the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova inc has received a report that, during priming, the tubing connected to the inlet of the arterial filter suddenly disconnected.There issue was identified prior to any patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The complained circuit was returned to livanova.A review of the dhr did not identify any deviations, non-conformities, or material scrap/requests relevant to the reported issue.Based on livanova investigation, a potential root cause of the tubing disconnection could be an alteration of the chemical/mechanical characteristics of the tubings.Additionally, insufficient gluing connection applied by manufacturing operators during the assembly might have contributed to the disconnection.The risk associated to the event is acceptable.No specific action is deemed necessary livanova will keep monitoring the market.

• Brand Name: SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10384937
• Report Number: 1718850-2020-00033
• Device Sequence Number: 19263759
• Product Code: DWE
• UDI-Device Identifier: 00803622124389
• UDI-Public: (01)00803622124389(240)220228(17)044027000(10)2005200026
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 044027000
• Device Lot Number: 2005200026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1