MAUDE Adverse Event Report: CAREFUSION/BD ALARIS LVP

Catalog Number 2426-0500

Device Problems Failure to Prime (1492); Product Quality Problem (1506); Improper Flow or Infusion (2954)

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

Event Date 12/12/2016

Event Type  malfunction  

Event Description

We are seeing product quality problem with care fusion iv tubing.Items 2426-0500 and 2420-0500 are failing during use causing back flow and failure to prime issues.This is happening across several lots at both of our facilities.

• Brand Name: ALARIS LVP
• Type of Device: ALARIS LVP
• Manufacturer (Section D): CAREFUSION/BD
• MDR Report Key: 6275698
• MDR Text Key: 65821069
• Report Number: MW5067429
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/23/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2426-0500
• Device Lot Number: 16107026,16107074
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1