MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS OXIMETRY CVC VANTEX; CATHETER, OXIMETER, FIBEROPTIC

Model Number X3816KT

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

This was a double lumen central line kit.Patient was status post open heart surgery.Had just returned from or when attempting to draw back blood, air was noted in the cvc lumen.Md notified and cvc discontinued.On removal of cvc and inspection of device, a small leak just below the hub was noticed.

• Brand Name: EDWARDS OXIMETRY CVC VANTEX
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 8653355
• MDR Text Key: 146497623
• Report Number: 8653355
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: X3816KT
• Device Catalogue Number: X3816KT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA