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

Model Number	044049201
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The leaking y-connector is the one in the revolution pump line.According to information, the leak was by the junction of the y connector.This connection is solvent bonded.Initial visual inspection of the returned connector found not abnormality.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has received report that, after one hour on bypass, patient blood started dripping from a y connector.Blood flow and pressures increased and the leak increased.Medical team tie banded the connection and added bone wax.The leak was not stopped.According to information, 1800 ml of patient blood was lost.Patient was administered a unit of blood.There is no report of any patient injury.
Additional Manufacturer Narrative
The complained sample returned to livanova for investigation.Visual inspection of the component did not reveal any cracks or damage as the source of the leak.Solvent was found present in all three legs of the wye-connector.A leak test confirmed the leak at the connection point between one harm of teh y connector and the tubing.Examination with uv light of the leaking connection allowed to clarify that the leak was due to insufficient solvent bonding distribution in the leaking poing.The dhr review confirmed the lot was released conforming to product specifications.Review of the livanova complaint databased did not identify any other similar complaint relevant to the complained pts pack code.Therefore, it can be considerated as an isolated case.Based on the above, the root cause was an operator error during the assembly of the line, who applied insufficient solvent to the component.The manufacturing personnel will be involved in a dedicated training meeting awaring of customer complaint.The risk is in the acceptable region.No other specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; lindberghstrasse 25; 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: 16636432
• Report Number: 1718850-2023-00025
• Device Sequence Number: 20643929
• Product Code: DWE
• UDI-Device Identifier: 00803622148637
• UDI-Public: (01)00803622148637(240)044049201(17)250131(10)2301200059
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 044049201
• Device Lot Number: 2301200059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown