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

Catalog Number	04404300
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information has been provided.According to provided information, the connection that disconnected was correctly secured with a tie (as per prduct ifu).The complained oxygenator, tubing and pump were requested for investigation.Dimensional analysis on the tubing revealed the inner diameter of the tubing was larger than defined by product specifications.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.Base on above results, livanova believe the most probable root cause of the disconnection was the larger inner diameter of the tubing.Involved tubings are supplied by a livanova supllier.The supplied has been officially informed of the present event.The risk is acceptable.No other action was deemed necessary livanova maintains monitoring the market.
Event or Problem Description
Livanova usa inc.Has received a report that, during a procedure, the inlet tubing of the oxygenator disconnected.The patient was administered of blood banck.There is no report of any patient injury.

• Brand Name: SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11347296
• Report Number: 1718850-2021-00025
• Device Sequence Number: 14482540
• Product Code: DWE
• UDI-Device Identifier: 00803622133466
• UDI-Public: (01)00803622133466(240)04404300(17)221031(10)2028900027
• 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
• 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
• Report Date (Section B): 01/20/2021

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: 10/31/2021
• Device Catalogue Number: 04404300
• Device Lot Number: 2028900027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1