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NaturaLyte Liquid Sodium Bicarbonate Concentrate - Potential Bacterial Contamination

Starting date:
June 20, 2015
Posting date:
June 20, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Contamination, Microbial Hazard, Suspected quality concern
Audience:
Healthcare Professionals
Identification number:
RA-53904

Audience

Hemodialysis Facility Medical Director, Clinical Manager, and Home Therapies Manager and Hemodialysis Home Patients

Please distribute to Healthcare Professionals who may administer or distribute the product to patients and post this notice in all relevant areas in your institution.

Key messages

  • One (1) bottle of NaturaLyte® Liquid Bicarbonate Concentrate, from a lot which was not distributed in Canada, exceeded Fresenius' internal bioburden release specification of 100 CFU/mL. The possibility that other lots manufactured in 2015 may be affected cannot be excluded.
  • At this time, these lots are not being recalled so as not to precipitate a shortage.
  • Risk mitigating measures are already in place to protect users from bacterial exposure and the potential risk of bacteremia (bacteria in the bloodstream) should contaminated dialysis concentrate be used during hemodialysis.
  • Fresenius Medical Care Canada is providing important safety information about additional risk mitigating steps that should be taken when using NaturaLyte® Sodium Bicarbonate Liquid Concentrate.
               

Issue

During a routine release and investigational testing of NaturaLyte® Liquid Sodium Bicarbonate Concentrate, one (1) bottle out of 2,351 (0.04%) tested positive for Dietzia sp ( colony forming unit (CFU) count of 2,790 CFU per mL). This result is out of internal specification for product release (the current CAN:CSA/ISO/AAMI standard of the final diluted dialysate is a colony count of less than 100 CFU per mL). The affected lot was not distributed in Canada, however the possibility that other lots manufactured in 2015 may also be affected cannot be excluded.

Products affected

NaturaLyte® Sodium Bicarbonate Liquid Concentrate (DIN:02230083)

Background information

This product is used in hemodialysis, which 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.

Fresenius Medical Care Canada has not received any reports of bacteremia with Dietzia sp. or positive dialysate cultures as a result of this issue, and the lot which had the elevated bioburden was not distributed in Canada. Nevertheless, Fresenius Medical Care Canada would like to provide important safety information about steps that can be taken by users of NaturaLyte® Liquid Sodium Bicarbonate concentrate to further mitigate the possibility of any harmful effects from using product with an elevated bioburden.

Dietzia sp is a gram positive coccobacillus and there is no risk of endotoxemia. A high bioburden in the dialysis concentrate may lead to bacteremia and pyrogenic reactions.

The following mitigation measures exist in the current hemodialysis system to reduce the risk of bacteremia and pyrogenic reactions:

  • The bacterial load from this contamination is significantly reduced by 96% as it is diluted (x26) in dialysis quality water, to form dialysate.
  • The use of an ultrafilter, such as the DIASAFEplus™ filter, in hemodialysis machines is an extremely effective barriers against bacteria.
  • The dialyzer membrane creates another effective barrier against bacteria.

Who is affected

Information for consumers

Patients using this product for home hemodialysis should contact their home program nurse if they have any questions about their dialysis treatment.

Information for health care professionals

Based on the published literature and the mitigations in place, Fresenius Medical Care Canada believes that the risk of bacteremia from dialysis treatment with the affected sodium bicarbonate concentrate is remote. However, as a precautionary measure, it is recommended that you monitor your dialysis patients for infections with any unusual bacteria, such as Dietzia. Please ensure that the following are in place at your clinic or home program to further mitigate the risk of bacteremia, should product with elevated bioburden be used to complete a treatment.

  • All hemodialysis machines in which this product is used should use a dedicated compatible online dialysis ultrafilter as per the operating instructions. The instructions regarding the maintenance and replacement of the ultrafilter, as outlined in the operating instructions, should be followed.
  • Ultrafilter membrane fibre integrity testing should be conducted before each use to ensure that it is intact. This step is performed automatically in the case of the Fresenius Medical Care 2008, 4008 and 5008 series of hemodialysis machines.
  • Instructions regarding the testing and maintenance of the hemodialysis machine and dialyzer should be strictly followed.
  • Instructions regarding machine disinfection should be followed.
  • Perform regular microbial testing to detect contamination if it were to occur.
  • Follow recommended storage directions as per the label.
  • Once product is opened, the sodium bicarbonate must be used within 24 hours.
  • If NaturaLyte® Liquid Sodium Bicarbonate Concentrate is used to produce online priming, bolus and rinse back fluid, or for hemodiafiltaration or hemofiltration, patients may be at higher risk if the ultrafilters fail.

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 situation and the implementation of necessary corrective and preventative actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of bacteremia with Dietzia sp or positive dialysate cultures with Dietzia sp or other serious or unexpected side effects in patients receiving NaturaLyte® Liquid Sodium Bicarbonate Concentrate should be immediately reported to the Fresenius Medical Care Canada Quality Department at 1-888-709-4411 x 3233 or to Health Canada.

Fresenius Medical Care Canada,
45 Staples Ave. Suite 110,
Richmond Hill Ontario L4B 4W6

To correct your email address or recall contact, contact Fresenius Medical Care Canada quality department at 1-888-709-4411 x3233.

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

Sincerely,

Original signed by

Julie Kubien
Director Quality Assurance and
Regulatory Affairs
Fresenius Medical Care Canada

References

  1. Oliver JC, Bland LA, Oettinger CW, et al. Bacteria and endotoxin removal from bicarbonate dialysis fluids for use in conventional, high-efficiency, and high-flux hemodialysis. Artif Organs. 1992 Apr;16(2):141-5.
  2. Gordon SM, Oettinger CW, Bland LA, et al. Pyrogenic reactions in patients receiving conventional high-efficiency, or high-flux hemodialysis treatments with bicarbonate dialysate containing high concentrations of bacteria and endotoxins. J Am Soc Nephrol. 1992 Mar;2(9):1436-44.

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.