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

Catalog Number 044009500

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

The complained circuit was not made available for investigation.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6) united states.The involved parts were not made available for return.The involved connection is not pre-assembled and it was not tied banded by the customer as suggested by the instruction for use.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Based on the investigations performed for similar cases, the root cause of the reported event was traced back to an alteration of the chemical / mechanical characteristics of the tubings (which are purchased by a livanova supplier).The supplier has been formally informed of the event.The risk is acceptable.Livanova will keep monitoring the market.

Event Description

Livanova usa inc.Has received a report that, during the procedure the inlet of the oxygenator tubing disconnected from the cardiopulmonary machine.The system is all preconnected except this pressure tubing that dislodged during the procedure.Patient outcome was not provided.A 3500a report (ref (b)(4)) was received at livanova on 16 mar 2021.

• 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
• 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: 11671616
• MDR Text Key: 245591012
• Report Number: 1718850-2021-00028
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622112324
• UDI-Public: (01)00803622112324(240)044009500(17)220930(10)2027400017
• 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,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• 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: 09/30/2022
• Device Catalogue Number: 044009500
• Device Lot Number: 2027400017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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
• Patient Age: 67 YR