MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS LIFESCIENCES TRUWAVE ARTERIAL LINE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number TRUWAVE 3CC/VAMP 60 IN.

Device Problems Crack (1135); Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

While priming new arterial line the rn noticed leaking from the tubing.Lower half of tubing was cracked and broken coming out of the package.Reporting potentially defective tubing edwards lifesciences truwave 3cc/vamp 60 in.Ref pxvmp160, lot 63581149, exp.2023-01-06.Fda safety report id# (b)(4).

• Brand Name: EDWARDS LIFESCIENCES TRUWAVE ARTERIAL LINE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 12878165
• MDR Text Key: 281506896
• Report Number: MW5105593
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: TRUWAVE 3CC/VAMP 60 IN.
• Device Catalogue Number: PXVMP160
• Device Lot Number: 63581149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1