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

Catalog Number 04404300

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

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 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
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 11347296
• MDR Text Key: 232742436
• Report Number: 1718850-2021-00025
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622133466
• UDI-Public: (01)00803622133466(240)04404300(17)221031(10)2028900027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1