Product Defect Correction Compounded Parenteral Nutrition and IV Solutions

HPS Pharmacies wish to give notice that Baxter, in consultation with the Therapeutic Goods Administration (TGA), has initiated a product defect correction for Compounded Parenteral Nutrition and IV Solutions.

For a full list of affected products, please click here.

This product defect correction has been initiated following increased reports of particulate matter in disposable inlets used with the ExactaMix (EM2400) Automated Compounding device used by Baxter Compounding for preparation of selected Parenteral Nutrition and IV Solutions. There is a risk that particulate matter may be present in final compounded solutions. There is no risk in relation to sterility of the tubing.

Baxter is working to replace the inlets affected by this issue. Until replacement stock is available, Baxter Compounding has ensured additional measures are in place to minimise the risk of particulates in compounded solutions, including:

• Inspecting the inlets prior to use in compounding;
• Priming the inlets prior to use; and
• Performing Visual Inspection on each filled compounded unit

Baxter also advises healthcare professionals to:

• Inspect and discard/return any product with visible particles; and
• Use an appropriate in-line filter set during the administration of any compounded solutions manufactured using the affected inlets. An in-line filter of not less than 1.2 micron should be used for administration of parenteral nutrition containing a lipid, a 0.22 micron filter can be used for aqueous solutions without a lipid (in line with international guidelines).

Please inspect your stock and quarantine any defect stock. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined, and HPS Pharmacies will arrange for a credit as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Baxter on 1800 229 837 or your pharmacist at HPS Pharmacies.

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