AUSTRALIA & NEW ZEALAND

Title Product Complaint Process - Fresenius Clinics

Code ANZ-NC-WI-RM&Q-003
Scope All ANZ Fresenius Clinics Staff
Purpose
To describe the requirements for processing and handling of FMC
consumables/product complaints within the Fresenius Clinics Division.
Creation Date 17-12-2015 Effective Date 17-12-2015 Date of next review December 2018
Fresenius Medical Care, SOP 00.026, Customer Complaints Handling, Aug 2014
European Economic Community (DIRECTIVE 93/88/EEC, Oct. 1993),
ANZ-NC-PM-RM&Q-001 Risk Management System
ANZ-NC-PM-RM&Q-002 Incident Reporting & Review Process
Related Documents ANZ-NC-PM-RM&Q-003 Risk Assessment & Management Process
ANZ-NC-PM-RM&Q-004 Quality Management System
Australian Guidelines for the Prevention and control of Infection Healthcare
IPC-4 Haemodialysis Standard Precautions
ANZ-NC-WI-HD-006 Management of a Blood Leak
Document Owner ANZ Fresenius Clinics

Document Author Trudy Bell – Allamanda Dialysis Clinic Manager

Approved By Adam Curnock, Lismore Dialysis Louisa Moloney, Acting Director of
Clinic Manager Endorsed By Nursing

Signature Date:
Signature Date:
Carolyn Chenoweth, ANZ IPC &
Quality Coordinator.

Signature: Date:
Change History 17-12-2015 Document created

Statement Only FMC products/consumables are to be sent back to the Fresenius

warehouse for investigation and must be in a Non-Contaminated state.

Any consumables/products with blood should be considered potentially

contagious with blood borne virus in accordance with Standard Precautions.

Under the European Economic Community Directive 93/88/EEC October. 1993,

Samples contaminated with blood fall into 2 categories:
Group 3 biological agent - means one that can cause severe human disease and
present a serious hazard to workers; it may present a risk of spreading to the
community, but there is usually effective prophylaxis or treatment available.

Group 4 biological agent means one that causes severe human disease and is a
serious hazard to workers; it may present a high risk of spreading to the
community; there is usually no effective prophylaxis or treatment available.

This work instruction will prevent biological contamination risk to workers and the
community.

ANZ-NC-WI-RM&Q-003 Product Complaint Process Fresenius Clinics Effective Date:17-12-2015

Page 1 of 2
 AUSTRALIA & NEW ZEALAND

Abbreviations • Contamination – product has been or potentially been contaminated by

blood or body fluids.
• CRS – Clinical Resource Specialist
• EEC – European Economic Community Directive
• Products/Consumables - Any products that are manufactured by FMC. This
includes all Haemodialysis Fluids, Bibags, dialysers, bloodlines, needles
and pre packed dialysis kits.
• FMC – Fresenius Medical Care
Work Instructions
Non Note These products do not need to be packaged into complaint kits.
contaminated Complaint samples are required for a thorough investigation of a product
samples quality complaint. If the sample is not contaminated and can be safely handled,
it should be immediately forwarded to:

Quality Assurance Manager

Fresenius Medical Care Australia Pty Ltd. (Smithfield)
305 Woodpark Road
Smithfield
NSW 2164 Smithfield
Australia
T: +61 2 8788 5914
F: +61 2 8788 5974
Contaminated Any consumables/products with blood should be considered potentially
samples contagious and NOT returned to the warehouse.

Obtain thorough details about the nature of the complaint.

Note the batch number of the product and take a photograph.

If the complaint is a dialyser blood leak, peel off the perforated sticker on the
dialyser and attach to the patient’s notes. Provide all details in reports as per
ANZ-NC-WI-HD-006 Management of a Blood Leak.
Incident reporting Inform the Dialysis Clinic Manager or Shift Coordinator of incident.
Document all incidents into electronic incident reporting tool and raise a
product complaint in lotus notes.
Documentation of Open lotus notes Complaint Management workspace.
complaint into Click on “create complaint”
Lotus Notes Choose the Account name from the drop down list
Database for all Fill out the general details page and then the second page “nature of the
FMC product/ complaint”.
consumable All fields marked with an asterisk (*) are mandatory fields and must be filled in.
complaints. Attach photo in complaint attachments section at the bottom of the form .
Once filled in, click on “process complaint” and close.

A customer acknowledgement receipt will be issued via email.

Notify the Local CRS of the nature of the complaint.

Evaluation Number and type of product complaints reported.
Reference http://www.anl.gov/sites/anl.gov/files/128725.pdf
Fresenius Medical Care, SOP 00.026, Customer Complaints Handling, Aug 2014

ANZ-NC-WI-RM&Q-003 Product Complaint Process Fresenius Clinics Effective Date:17-12-2015

Page 2 of 2