Print | Need Larger Text? | Share

Alaris PC unit (model 8000) - Total Bolus Display Error - Notice to Hospitals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 67 K)

Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Alaris PC unit (model 8000)

September 7, 2010

To Alaris^® System users,

Please distribute to relevant Departments: Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care, Risk Management, Biomedical Engineering and post this Notice in your institution.

Subject: Alaris PC unit (model 8000) with total bolus display error

Required Action for Users:

1. Attach the provided Warning Tags to each PC Unit model 8000.
   
   
   Warning Tag: The model 8000 PC unit, when used with an Alaris Pump module or Alaris Syringe module may under certain conditions display an incorrect total dose when programmed to deliver a bolus dose. The Alaris Pump module or Alaris Syringe module delivers the actual programmed bolus dose (and associated volume to be infused) regardless of the displayed total bolus dose.
   
   
2. Notify clinicians to disregard the total bolus dose display.
3. As a good practice, always verify the infusion parameters are entered correctly.
4. The hospital pharmacist should verify that the Guardrails^® software is used for their hospital’s bolus dose entries.
5. Evaluate the risk/benefit of using the bolus feature for the delivery of IV medication. If deemed necessary, the drug library can be updated by hospital’s pharmacy to remove the bolus feature from drugs with continuous infusion units that are 1000 times lower than the bolus dose units (e.g., mcg for continuous infusion and mg for bolus dose).

Follow-up Actions by CareFusion: CareFusion is working to release a software update to address this display error and will contact facilities as soon as the software update is available. CareFusion does not require that you return your devices. Clinicians should weigh the risk/benefits to the patients before continuing the use of the device.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of total bolus display error or other serious or unexpected adverse incidents for medical devices in patients using Alaris PC unit model 8000 should be reported to CareFusion or Health Canada at the following addresses:

Sincerely,

original signed by

Michelle J. Badal, RAC
Vice President, Regulatory Affairs, Infusion