Report a Medical Device Product Quality Issue

Our Product Complaint and Support team is dedicated to our company's core values built upon a foundation of caring for life. We are available to assist you in fully addressing any concerns in a knowledgeable, effective and timely manner. To make the process as easy as possible, we provide the following services:

  • Personal attention to each individual inquiry
  • Dedicated associate per product line
  • Various methods for reporting product quality issues such as: email, fax, phone, online reporting site
  • Investigation letters upon request
  • E-Receipts acknowledging the current status of the complaint, if an investigation letter is requested
  • Customer satisfaction surveys
  • Shipping materials and labels provided for sample return upon request

Important: If reaction or injury has occurred, please seek medical assistance immediately. Please report the reaction or injury to Fresenius Kabi as soon as posible at 1-800-933-6925.

If you wish to report a product quality issue with a Fresenius Kabi product, please contact us at:

Toll Free: (800) 933-6925
Fax: (888) 858-2983
Email: mdpmqa.usa@fresenius-kabi.com
Online: Online Product Performance Report Site
 

Complaint Process Overview

For information on the Fresenius Kabi Medical Device Disposable Complaint Process, please click here.
 

Online Product Performance Site

Product Perform Tool Image

Find out more by clicking here

When reporting online, please note you will need to request a User ID.

Online Report Site Training Resources

Quick Guide: How to Submit an Online Performance Report

Online Product Performance Reporting Site Training Guide

Fax or Email

Visit our Online Report Site Link to request membership and submit a complaint directly online. Click "Request Membership" to sign up.

When submitting a complaint via email or fax, please complete and attach the appropriate form below:

 

Medical Device Disposables

Fenwal Bioflex RC BPU COM.TEC Therapeutic Plasma Exchange (TPE)
INfusia Agilia-Infusion
Alyx Amicus
Amicus Mononuclear Cell (MNC) Amicus Therapeutics (TPE/RBCX)
Aurora-Xi 4R2215 Code for Plasmapheresis
Plasmapheresis CATS Disposable Set
Whole Blood Solutions 

Laboratory Device Disposables

LOVO X6R4902 LOVO X6R4906
LOVO X6R4906A LOVO X6R4907
LOVO X6R4909 LOVO X6R4909A
LOVO X6R4917  

 

Sample Return Packaging Instructions

For information on how to return samples associated with a complaint, download the Instructions for Packaging sheet.