Hospira Inc., GemStar Infusion System - Damage from Battery Leakage

Recall Class: Class I

Date Recall Initiated: March 18, 2013

Product: GemStar Infusion System

All GemStar Infusion Systems are affected by this recall.

Models: 13000, 13100, 13150, 13086, 13087, 13088

Manufacturing and Distribution Dates: February 1999 through April 2013

Use: The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products.

Recalling Firm:
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045-2579

Reason for Recall:

Damage from Battery Leakage May Cause the Device to Shut Off Without Warning.

Power can be lost when the pump loses contact with the batteries, or when components on the Middle Printed Wire Assembly (PWA) fail, or when the Middle PWA does not receive appropriate signals from elsewhere in the pump. Loss of contact can be due to a mechanical disconnect at either the positive or negative battery terminal. Inappropriate or missing input signals can be due to contamination, corrosion damage, electronic defects or keypad problems disrupting turn on/turn off signals.

If the internal AA batteries leak, their contents will cause damage to the device’s internal components which may result in the device shutting off without issuing a warning or an audible or visual alarm. If the device shuts off, it will result in a delay or interruption in therapy.

The clinical impact of a delay and/or interruption in therapy is dependent upon the clinical condition of the patient and the product being infused. Therefore, a delay/interruption in therapy can potentially result in significant injury or death.

Health care professionals are advised to weigh the risks and benefits to patients before using the device to administer critical therapies. Customers should consider the use of an alternative product, particularly in patients in which a delay/interruption in therapy could result in significant injury or death.

Public Contact: For additional information or technical assistance, contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4 (Available 24 hours a day/7 days a week).

FDA District: Chicago District Office

Additional Recall Information:
As directed by the GemStar Standard Operating Manual, the internal AA batteries and battery compartments should be inspected for signs of leakage, corrosion, or other damage prior to each use. In addition, each time the batteries are replaced, the battery compartment should be inspected for damage.

Always replace both batteries at the same time with disposable alkaline-type batteries. Batteries that have exceeded their expiration date should not be used in the device, including when being used as the back-up power source along with the Power Adaptor, Docking Station, or the Battery Pack.

If a device exhibits damage caused by leaking batteries, immediately remove it from clinical service and contact Hospira at 1-800-441-4100 to arrange for return of your device for repair.

If a health care facility's ability to administer proper care is severely impacted by this issue, Hospira will provide loaner devices.

On March 18, 2013, Stericycle Inc., Indianapolis, Indiana, on behalf of Hospira, Inc., sent an "IMPORTANT DEVICE INFORMATION" letter, including a reply form, to Hospira’s customers. The firm asked customers to complete the reply form to the fax number or email address on the form, even if they do not currently have the impacted devices.

Contact Stericycle at 1-877- 496-5038 (Monday to Friday, 8 AM to 5 PM Eastern Standard Time) to obtain additional copies of the reply form.

For customers who have further distributed these devices, please notify your accounts who may have received these infusers and ask them to contact Stericycle to receive a reply form.

For further inquiries, contact Hospira using the information provided below.

Hospira Global Complaint Management

1-800-441-4100 (M-F, 8am to 5pm, Central Standard Time) ProductComplaintsPP@hospira.com

To report adverse events or product complaints

Hospira Advanced Knowledge Management

1-800-241-4002, option 4
(24 hours a day/7 days a week)

Additional information or technical assistance

About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.