MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC VAMP; CATHETER, CONTINUOUS FLUSH

Catalog Number 48VMP106

Device Problems Backflow (1064); Leak/Splash (1354); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2021

Event Type  malfunction  

Event Description

When changing the art-line tubing i noticed a leak within the new vamp.This leak caused a back flow of blood into the line, making the pressure inaccurate.

• Brand Name: VAMP
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12347722
• MDR Text Key: 267456720
• Report Number: 12347722
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 48VMP106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1