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

Catalog Number 046007400

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2020

Event Type  malfunction  

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 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.

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 Description

Initial report.

• Brand Name: SMARXT TUBING AND CONNECTORS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11176430
• MDR Text Key: 226992934
• Report Number: 1718850-2021-00022
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622138119
• UDI-Public: (01)00803622138119(240)046007400(17)220430(10)2010400032
• Combination Product (y/n): N
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1