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NaturaLyte Sodium Bicarbonate Liquid Concentrate - Possible Bacterial Contamination

Starting date:
May 15, 2015
Posting date:
May 15, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information, Contamination
Audience:
Healthcare Professionals, Hospitals, General Public
Identification number:
RA-53423

Audience

Hospitals, Haemodialysis Clinics, Home Haemodialysis Programs and Patients who may have received this product. Please distribute to Healthcare Professionals who may administer the product to patients and post this notice in all relevant areas in your institution.

Key messages

  • Fresenius Medical Care has determined that specific lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate may contain higher levels of bacterial contamination than acceptable.
  • Bacterial contamination poses a potential risk of bacteremia (bacteria in the bloodstream) from the contamination of dialysis concentrates.
  • Do not use product from the affected lots (see “Products Affected” section below).
  • Use only NaturaLyte® Sodium Bicarbonate Liquid Concentrate product from lots not affected by the recall or an alternative product.

                 

Issue

Fresenius Medical Care is voluntarily recalling specific lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate in 6.4L and 8L volumes due to possible bacterial contamination.

This product is used in a form of dialysis (haemodialysis) that removes waste products from the blood by passing the blood out of the body through a filtering system and returning the cleaned blood to the body.

The affected product was distributed to hospitals and home settings between May 20, 2014 and May 8, 2015. Users should check lots (see “Products Affected” section below) prior to administering or using this product.

Products affected

NaturaLyte® Sodium Bicarbonate Liquid Concentrate (DIN:02230083) in 6.4L and 8L volumes with lots that begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMLB, 14NMLB, 14PMLB, and 14SMLB.

Background information

One lot of NaturaLyte® Sodium Bicarbonate Liquid Concentrate showed elevated bioburden results during ongoing stability shelf life testing. Three different lots were destroyed and never distributed on the market when they exceeded the acceptable level for bioburden. The possibility that other lots manufactured in 2014 might also show growth could not be excluded.

The risk of bacteremia is directly related to patient bacterial exposure. Several measures, including the use of the Diasafe filter or equivalent, and the use of a dialyzer, significantly reduce the risk but do not completely eliminate it.

Who is affected

Information for consumers

  • Do not use the affected lots.
  • Use only NaturaLyte® Sodium Bicarbonate Liquid Concentrate from lots not affected by the recall or an alternative product.
  • Dialysis schedules should not be interrupted without appropriate assessment and direction by the prescriber. If alternatives are not available, then contact and follow the advice of your healthcare professional regarding your dialysis treatment.
  • If affected product was used previously on the dialysis machine, the dialysis system should be disinfected (including heat) prior to initiation of patient treatment with unaffected product.
  • Report any adverse events to Health Canada.

Information for health care professionals

Hospitals and home haemodialysis programs should:

  • Immediately examine your stock to determine if you have any of the affected product lots, discontinue use of affected product and place these units in a segregated, secure area.
  • Contact any home haemodialysis patients who may have received affected product to inform them of the recall, not to use product from the affected lots and ensure that they have replacement or an alternative product.
  • If affected product was used previously on the dialysis machine, the dialysis system should be disinfected (including heat) prior to initiation of patient treatment with unaffected product.
  • Product from affected lots should be returned as outlined in the Recall Notice issued by Fresenius Medical Care Canada on May 14, 2015.

If you have any additional concerns or questions, please contact the quality department at: 1-888-709-4411 or email: julie.kubien@fmc-na.com.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and to the public through its MedEffect Canada website. Health Canada is also monitoring the recall and the implementation of necessary corrective and preventative actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious bacteremia, infection or unexpected side effects in patients receiving NaturaLyte® Sodium Bicarbonate Liquid Concentrate should be reported to Fresenius Medical Care Canada or Health Canada.

Fresenius Medical Care Canada, Inc.
1-888-709-4411
julie.kubien@fmc-na.com

To correct your mailing address or fax number, contact Fresenius Medical Care Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
     
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone:1-800-267-9675
Fax:1-613-946-5636

Original signed by

Julie Kubien, B.Sc.
Director Quality and Regulatory Affairs
Fresenius Medical Care Canada, Inc.

For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.