Models 13000, 13100, 13150, 13086, 13087, 13088
UPDATED 05/01/2013. 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.
AUDIENCE: Risk Manager, Biomedical Engineering, Nursing
ISSUE: Hospira notified healthcare professionals of a Class I recall of the GemStar Infusion System, Models 13000, 13100, 13150, 13086, 13087, 13088. When the GemStar Lithium battery voltage level drops below 2.4 volts, an "11/004" error is displayed and the device is rendered inoperable. This failure mode results in a delay/interruption of therapy. Additionally, infusion settings and event history logs will be erased as a result of this device malfunction.
The severity of the clinical impact, due to the delay/interruption in therapy, is dependent upon the underlying condition of the patient and the treatment being prescribed. A delay/interruption in therapy has a worst case potential to result in a significant injury or death.
The affected units were manufactured and distributed between February 1999 and April 2013.
BACKGROUND: 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.
RECOMMENDATION: The customer notification letter stated that lithium batteries that are older than three (3) years should be replaced. Contact the Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, 24 hours a day/7 days a week, to determine if your battery needs to be replaced and if necessary to arrange for the return of your device to perform battery replacement. Facilities that periodically retrieve the history logs from their GemStar Infusion System should consider retrieving them more often to reduce the amount of history log information that would be lost should this failure occur.
Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178