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

Catalog Number 627373301

Device Problem Disconnection (1171)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Sorin group italia manufactures the smart perfusion pack.The incident occurred in burlington, vermont, united states of america.The complained tubing is available and has been requested.According to follow up with the customer, the patient is doing fine.They estimated blood loss was around 500-1000 ml blood loss.However, it was stated to be hard to determine the real loss volume.A piece of the tubing that disconnected has been requested for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Livanova usa has received a report that the tubing from the oxygenator suddenly separated during a procedure while blood flow was 5.5 lpm.The disconnection was quickly discovered, tube was reconnected and secured with a tie band.Patient blood flow was restarted at over 6.0 liters per minute and the procedure was completed uneventfully.Patient showed a very transient hypotension.There is no evident harm to the patient.According to perfusionist, connection was double checked as per hospital checklist.Nothing seemed amiss.Perfusionist stated that, from now on, all connections will be tie banded.Connection that disconnected was with a competitor oxygenator.The complained oxygenator is going to be returned to the competitor.

Manufacturer Narrative

Livanova received a report stating that during a procedure, the tubing suddenly separated from the oxygenator (not manufactured by livanova).This tube was promptly re-attached and secured with a tie band.There is no report of any patient injury.Neither any picture nor the complained tubing was provided.The dhr review of the complained lot confirmed the devices was released conforming to product specifications.Review of livanova complaints database did not identify any other similar event related to the circuit item code.The complained tubing is supplied by a livanova supplier.Livanova incoming controls resulted conforming to specifications and no anomaly was detected at the incoming inspection.It cannot be ruled out that the root cause of the reported event was a not-compliant dimension of the oxygenator port or a suboptimal connection between tubing and oxygenator.This connection is done by the user.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: COBE 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: 15585427
• MDR Text Key: 301554670
• Report Number: 1718850-2022-00054
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622135446
• UDI-Public: (01)00803622135446(240)627373301(17)231130(10)2130800069
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 627373301
• Device Lot Number: 2130800069
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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