Plum A+ Infusion Pumps - Recall Due to Audible Alarm Failure - Notice to Hospitals

Contact: Marketed Health Products Directorate

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

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Hospira Plum A+ Infusion Pumps

February 14, 2011 (An update to this recall was issued on 07/03/2011.)

Dear Healthcare Professional:

Please distribute to relevant Departments (Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required), and other involved professional staff and post this Notice in your institution.

Subject: Recall of all Plum A+ Infusion Pumps due to audible alarm failure

Product	List Number
Plum A+ Hyperbaric Infusion Pump	11005
Plum A+ Infusion Pump	12391
Plum A+3 Infusion Pump	12618
Plum A+3 with Hospira MedNet Software	20678
Plum A+ with Hospira MedNet Software	20679
Plum A+ Driver	20792

Hospira, Inc. has received customer reports of the Plum A+™ infusers in which the audible alarm has failed. If the audible alarm fails and the user does not notice the visual alert, the user may not be aware of the change in pump status such as air-in-line or occlusion. This may result in a delay or interruption of therapy which may result in serious injury and/or death. Hospira has received reports of this failure in Canada and has received reports of serious patient injury related to this failure outside of Canada.

Hospira's investigation concluded the primary root cause is associated with failure of the piezoelectric assembly ("buzzer") due to improper mounting of components on the board assembly, poor solder application and breakage of internal wiring connections.

To continue using the devices, Hospira recommends that trained personnel perform an audible alarm test prior to each clinical use of the device (during the pump cleaning process).  Do not perform this test while the pump is being used on a patient.   Note that this test will identify if the alarm has already failed.  However, even if a pump successfully passes this test, this does not guarantee that the alarm will not fail during the next clinical use.

To perform the test:

1. Install an empty (dry) set or an empty (dry) test cassette.
2. Turn on the infuser.
3. When the pump detects the empty cassette, listen for the audible alarm. 
4. If the alarm is audible, remove the empty cassette and continue to use the infuser. If the alarm is not audible, discontinue use of the infuser and contact Hospira Global Product Safety and Complaints.
5. For Plum A+3 devices, be sure to test each infusion channel separately.

Hospira personnel will provide additional training support as needed to ensure staff members have a clear understanding of the alarm test procedure.  Please contact your Hospira representative to request training support.

Hospira is developing a design improvement to resolve this issue.  Validation of this solution for all device configurations is in progress.  Once the redesign activities are complete and inventory is available, Hospira will notify customers to schedule replacement of the buzzer assemblies.

If a device fails, or you elect to remove an infuser from service, please contact Hospira using the information provided below.

Hospira Contact	Contact Information	Areas of Support
Canadian Service Center	1-866-488-6088 Option 5	To report adverse events or product complaints
Hospira Clinical Support	1-866-488-6088 Option 4	Additional information / Clinical Assistance

Please complete the attached Reply Form and return it via fax to the number on the form.

This correction is being made with the knowledge of Health Canada.

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 alarm failure or other serious or unexpected adverse incidents for medical devices in patients using Plum A+ Infusion Pumps should be reported to Hospira, Inc. or Health Canada at the following addresses:

Sincerely,

original signed by

Beryl Chan
Regional Director, Quality & Regulatory Affairs

Urgent Device FIELD CORRECTION Reply Form.

RESPONSE REQUIRED

No Audible Alarm (February 14, 2011)

PLUM A+™ Family of Infusers

COMPLETE THE INFORMATION AND FAX THE COMPLETED FORM TO 1-877-906-0208.

1. I have received the Customer Notification and distributed it to users throughout the facility:
   • YES
   • NO
   • If NO, state reason:

Customer Information

Business Name

Address/City/Province/Postal code

Hospira Customer Number (if applicable)

Contact Name

Contact Phone/e-mail Address

Completed by: Printed Name/Signature/Date