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

Catalog Number 627417401

Device Problem Defective Component (2292)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Livanova usa inc manufactures the cobe smarxt tubing and connectors.The incident occurred in (b)(6) united states of america.The involved device has been requested for return.Initial visual inspection confirmed the reported condition: one y connector of the circuit is not patent.Livanova has opened a non-conformity report and has formally informed the supplier of the component.Investigation is on-going if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa received a report that during the initial dose of delivery of the cardioplegia, there was no flow of the cardioplegic solution.Medical team elected to remove the cross-clamp and to wean the patient from bypass until the cardioplegia set was replaced.A new cardioplegia set was installed, primed and was the procedure was completed with no issue.There is no report of any patient injury.

Manufacturer Narrative

The available information have been evaluated by livanova medical assessment team and the event was reassessed as not reportable since no seriuos injury can occur and the issue is a surgery discomfort.In addition, the issue is always detectable at least before the injection of the first cardioplegic dose and the change-out of the cardioplegic circuit can be done without any patient detrimend even during a procedure.Accordingly, livanova has not been informed of any patient injury for any similar event.Visual inspection of the returned sample has confirmed the occlusion.The supplier of the connector has been formally informed of the issue.The investigation is on-going if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

Manufacturer Narrative

At the submission of the case, the customer provided a clear picture showing the reported defect showing one harm of the wye connector was not patent.The dhr review highlighted that the complained lot was released conforming to product specifications.Review of the livanova complaint database identified that in total 13 events were registered relevant to the occlusion of this wye connector.In all events, the lot of the wye connector was the same.Livanova performed a visual inspection of the same wye connector item still in the warehouse and found no defect.Therefore, not all units of the complained lot are occluded.The complained wye connector in bought from a livanova supplier.The supplier has been formally informed of the issue.Investigation at the supplier site suggested that the most probable root cause was incorrect manual assembly of one of the mandrels for the deep molding of the connector.To prevent reoccurrence, the following actions have been implemented: (i) replace socket head screw with set screw so the screw will be completely flushed to the surface, and this will prevent accidental screw loosening; (ii) inspect the tools for misalignment before starting the production; (iii) perform 100% inspection before delivery.Since the risk is in the acceptable region, no other corrective action is deemed necessary.Livanova will maintain 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: 13506035
• MDR Text Key: 288792372
• Report Number: 1718850-2022-00021
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622144431
• UDI-Public: (01)00803622144431(240)627417401(17)231231(10)2135000050
• 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,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 627417401
• Device Lot Number: 2135000050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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
• Patient Outcome(s): Required Intervention