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New Hospira infusion pumps still not available for sale: Company continues to address device issues
- Starting date:
- March 13, 2014
- Posting date:
- March 13, 2014
- Type of communication:
- Information Update
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public
- Identification number:
- RA-38391
- Issue
- What you should do
- What industry professionals should do
- Report health or safety concerns
- Related AWRs
- Media enquiries
- Public enquiries
Issue
Health Canada is updating hospitals and purchasers for clinics, homecare and hospices that no new intravenous infusion pumps manufactured by Hospira Inc. will be available for sale or distribution until the company completes corrective measures to address ongoing design and quality concerns. In March 2013, Hospira voluntarily stopped all sales of its infusion pumps. While progress has been made, the voluntary stop sale remains in effect until all issues are resolved.
The affected Hospira infusion pumps include: Plum A+ Infusion System; LifeCare PCA Infusion System; GemStar Infusion System; and the Symbiq Infusion System. The GemStar Infusion System and the Symbiq Infusion System are being discontinued and are no longer licensed for sale in Canada.
Health Canada continues to closely monitor Hospira's corrective measures in order to resolve all remaining issues associated with the use of these devices.
Hospira will continue to communicate necessary information with hospitals and purchasers for clinics, hospices and homecare use about pumps that are already in use. Notices and recommended actions are available on the company's website and on the Healthy Canadians website. Canadians and healthcare professionals can contact Hospira for updates regarding its various infusion pumps, pump accessories and the ongoing design and quality concerns by phone at 1-866-488-6088 or by email.
What you should do
- Patients using these devices in a home setting are encouraged to contact their Hospira infusion pump provider regarding any questions or concerns.
- Patients should not stop using their infusion pump unless advised to do so by their healthcare provider.
What industry professionals should do
Additional information for hospitals and healthcare facilities:
- Health Canada recently received a report that a Hospira Plum A+ pump was found to have an incorrectly positioned part resulting in a free flow of IV fluid when the door was opened. As a result of this recent incident, healthcare professionals are reminded to follow good clinical practices by ensuring that tubing is clamped when the door of an infusion pump is opened to avoid a potential risk of unrestricted gravity flow.
- Healthcare professionals are also reminded to be aware of notices regarding recalls and recommended actions.
- Facilities wishing to purchase new pumps or that are preparing for the decommissioning of existing pumps can find information on all infusion pumps currently licensed in Canada by searching Health Canada's Medical Devices Active Licence Listing database.
Report health or safety concerns
Complaints about medical devices can be reported to the Health Canada’s Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Related AWRs
Media enquiries
Health Canada
(613) 957-2983
Public enquiries
(613) 957-2991
1-866 225-0709