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

Catalog Number	046007400
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information has been provided.The circuit is not available for investigation.A review of the dhr was not possible as no lot was provided.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc.Has received a report that, during a procedure, the tubing at inlet of the inspire oxyggenator slipped off.Perfusionist reconnected the tubing and resumed bypass without incident.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report stating that connection between the revolution disposable pump and the inlet of the oxygenator disconnected during the procedure.The involved parts (oxygenator, tubing and pumps) were not made available for return.According to follow up information with the customer, the connection that disconnected as not tie-wrapped, as recommended in the product instruction for use.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.Based on all the gathered information, the most likely root cause of the reported tubing disconnection was an alteration of the chemical / mechanical characteristics of the tubings (which are supplied by a supplier).The supplier was formally notified.The risk is acceptable.No other action will be undertaken.Livanova will keep monitoring the market.H3 other text: device not available.
Event or Problem Description
Initial report.

• 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: 11176430
• Report Number: 1718850-2021-00022
• Device Sequence Number: 2231697
• Product Code: DWE
• UDI-Device Identifier: 00803622138119
• UDI-Public: (01)00803622138119(240)046007400(17)220430(10)2010400032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/16/2021

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: 04/30/2022
• Device Catalogue Number: 046007400
• Device Lot Number: 2010400032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1