CLINOLEIC 20% - Potential for the Presence of Particles from the Administration Port Material - For Health Professionals

Starting date:

July 16, 2013

Posting date:

July 16, 2013

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-34659

This is duplicated text of a letter from the Baxter Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on CLINOLEIC (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) 20%

July 16, 2013

Dear Health Care Professional,

Subject: Detachment of Blue Membrane Disc from Administration Closure (Twist Off Protector) of CLINOLEIC 20% - Lipid Emulsion for Intravenous Nutrition (DIN: 02344327), Product Codes CJDB9501 250 mL, CJDB9503 500 mL, CJDB9504 1000 mL

Baxter Corporation in collaboration with Health Canada is providing you with Important Safety Information regarding the potential for introducing particulate matter into CLINOLEIC 20% while spiking the administration port.

CLINOLEIC 20% is indicated for Parenteral Nutrition (PN) in adults when oral or enteral nutrition is not possible, insufficient, or contraindicated. As a lipid emulsion, CLINOLEIC 20% provides a source of fat (or lipids) for adult patients requiring parenteral nutrition.

Baxter Corporation has recently received product complaints in Canada for full detachment of the sterile blue membrane in CLINOLEIC 20% emulsion after spiking with a transfer or administration set.

• Detachment of the sterile blue membrane in CLINOLEIC 20% emulsion can occur after spiking the administration port. This could potentially result in particulate matter entering the emulsion.
• Particulate matter (greater than 5 micron) has the capability of obstructing blood flow through capillaries, which could lead to complications such as embolism.
• In accordance with the American Society of Parenteral and Enteral Nutrition  (ASPEN) guidelines for Parenteral Nutrition formulations, Baxter recommends that in-line filters should be used on administration sets regardless of Parenteral Nutrition formulation (i.e. Total Nutrient Admixture or separate IV Lipid Infusion) or clinical setting (i.e. by patients in home use or hospitals and clinics) in order to mitigate the risk of particulate matter during infusion.

According to ASPEN 2004 Guidelines on Safe Practices for Parenteral Nutrition ^{Footnote 1} the use of 1.2 micron in-line filtration for PN formulations with lipids is recommended to remove particulate matter and micro-precipitate contamination. Baxter recommends following the ASPEN Guidelines for PN formulations containing CLINOLEIC 20%. If you are using an administration set without a 1.2 micron filter, it is recommended to add the 2H8603 Clearlink 1.2 micron filter Extension Set or 2C1103 Interlink 1.2 micron filter Extension Set to the set. If you use a non-Baxter administration set without a 1.2 micron filter, please consult the manufacturer for appropriate options to include a 1.2 micron filter.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.

Any case of serious or unexpected adverse reactions in patients receiving CLINOLEIC 20% should be reported to Baxter Corporation or Health Canada.

Baxter Corporation

7125 Mississauga Rd, Mississauga, Ontario L5N 0C2

1-888-719-9955
canada_productsurveillance@baxter.com

To correct your mailing address or fax number, contact the Baxter Corporation.

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, please contact Health Canada at:

Health Product and Food Branch Inspectorate

E-mail: DCVIU_UVECM@hc-sc.gc.ca

Telephone: 1-800-267-9675

Fax: 613-946-5636

Sincerely,

Original signed by

Phil Lynch

Director, Quality,

Baxter Corporation