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

Catalog Number 044026202

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Livanova usa inc.Manufactures the convenience pack.The incident occurred in (b)(6), united states.The complained circuit was returned to livanova 30 oct 2020.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.The risk associated to the event is acceptable.No specific action is deemed necessary.Livanova will keep monitoring the market.

Event Description

Livanova usa inc.Has received a report that, during bypass procedure, the tubing from the outlet of the centrifugal pump into the oxygenator inlet, fell off.The medical team elected to administer blood bank to the patient.There is no report of any patient injury.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA 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 80004
• MDR Report Key: 10821608
• MDR Text Key: 227072790
• Report Number: 1718850-2020-00041
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622140020
• UDI-Public: (01)00803622140020(240)044026202(17)220228(10)2004400020
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 044026202
• Device Lot Number: 2004400020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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